Relapsing Remitting Multiple SclerosisPhase 1MS-BIOMENCT03594487

Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis

A Phase 1 study testing FMP30 Donor Stool and Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool in people with Relapsing Remitting Multiple Sclerosis, run by Jeffrey Gelfand at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Relapsing Remitting Multiple Sclerosis
What is being tested?: FMP30 Donor Stool and Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 16 Nov 2018to 16 Dec 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 18-60 inclusive (at time of screening).
Diagnosis of relapsing-remitting multiple sclerosis (MS) by the International Panel McDonald Criteria (2010)(1), incorporating 2017 revisions, which reclassify select high-risk Clinically Isolated Syndromes under 2010 criteria as RRMS under 2017 criteria, and Lublin criteria (2014)(2). [RRMS: relapsing remitting multiple sclerosis]
Recent documented MS disease activity, defined as at least 1 clinical relapse within the past 1 year prior to baseline OR 2 clinical relapses in the past 2 years prior to baseline OR at least 1 new T2/FLAIR lesion on brain or spine MRI OR at least 1 gadolinium enhancing lesion on brain or spine MRI in the past 1 year prior to baseline.
Expanded Disability Status Scale (EDSS) less than or equal to 6.0; EDSS 5.5 or less if MS disease duration is greater than 15 years (no other disease duration restriction).
Must have positive serology for Epstein-Barr Virus (EBV) (IgG anti-EBNA positive) at screening, indicating prior exposure. [EBNA: Epstein-Barr nuclear antigen]
No prior MS disease-modifying therapy or a 12-week washout period for participants on glatiramer acetate or interferon-beta therapy.

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At least 4 weeks from baseline since last use of IV or oral glucocorticoids. Protocol: MS-BIOME Study.
Agree to maintain a stable diet during the course of the study (over-the-counter probiotics are allowable).
Premenopausal women and women <12 months after the onset of menopause must have a negative serum pregnancy test unless they have undergone surgical sterilization.
Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use a highly effective method of contraception; non-sterilized male participants who are sexually active with a female partner of childbearing potential must agree to use a highly effective method of contraception.
Not actively participating in another interventional MS clinical trial (participation in other observational research studies is allowable).

Who cannot join

Prior use of fingolimod, dimethyl fumarate, teriflunomide, natalizumab, alemtuzumab, mitoxantrone, cyclophosphamide, rituximab, ocrelizumab, daclizumab, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, leflunomide, or induction chemotherapy.
No use of diuretics like furosemide (Lasix) 1 week before the first dose of oral antibiotics. The use of hydrochlorothiazide (HCTZ) for hypertension at a dose < 50 mg/day is allowable.
Progressive MS by Lublin criteria (2014).
No oral or IV antibiotics are allowed within 8 weeks prior to screening and within 12 weeks prior to the planned FMT procedure (for participants in the FMT arm) or prior to the first stool collection (for participants in the control arm). (Note that topical, otic, ocular antibiotics are specifically allowable, which is consistent with the IMSMS.org protocol for collaborative gut microbiome research in MS). [IMSMS: International MS Microbiome Study]
Hypersensitivity or allergy to study antibiotics, conscious sedation medications, or bowel preparation.
Contraindication to study procedures, including MRI, anesthesia (ASA criteria IV and V), colonoscopy, and phlebotomy.

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History of inflammatory bowel disease (Crohn's Disease, Ulcerative Colitis) Protocol: MS-BIOME Study.
Active symptomatic C. Difficile infection (colonization is not an exclusion).
Active gastrointestinal condition being investigated (i.e. GI bleeding, colon cancer, active GI workup); history of known or suspected toxic megacolon and/or known small bowel ileus, major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment (note that this does not include appendectomy or cholecystectomy); or history of total colectomy or bariatric surgery.
History of malignancy (except excised cutaneous basal cell carcinoma or squamous cell carcinoma, which are allowable), including no concurrent induction chemotherapy, radiation therapy, or biological treatment for active malignancy.
Pregnant or lactating women or intention of getting pregnant during the trial period.
Active infection, including untreated latent or active tuberculosis, HIV, hepatitis, syphilis, or other major active infection.
Known immunodeficiency, including Common Variable Immunodeficiency (CVID).
INR>1.5, Platelets<100, Hemoglobin <8.5, WBC<2.0, Absolute lymphocyte count <0.8, Absolute Neutrophil Count <0.5, CD4<200, eGFR<45. [INR: international normalized ratio, WBC: White Blood cell, CD4: cluster of differentiation 4, eGFR: epidermal growth factor receptor]
Any condition that in the opinion of the study PI could jeopardize the safety of the participant, would make it unlikely for the participant to complete the study or could confound the results of the study.
Unable or unwilling to comply with study protocol requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCSF Multiple Sclerosis Center
San Francisco, California, 94158

Other trials in United States

About this study

Official title: Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune Function

In this Phase 1b open-label prospective clinical trial, patients with relapsing-remitting MS will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints will be assessed at various time points. The active phase of the study will continue for 12 weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel observational control arm of MS patients who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures. The study duration for the Observational Control Arm is 12 weeks.

Read the detailed description

In this Phase 1b open-label prospective clinical trial, patients with relapsing- remitting MS will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints will be assessed at various time points. The active phase of the study will continue for 12 weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel observational control arm of MS patients who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.

The primary hypotheses are that:

FMT will be safe and tolerable in patients with MS.
FMT preceded by antibiotic preconditioning will lead to a change in fecal microbiota community structure.

Secondary hypotheses are that:

FMT preceded by antibiotic preconditioning will induce a favorable shift from pro-inflammatory to immunomodulatory T cell profiles in patients with relapsing-remitting MS.
That engraftment will not appreciably decay over time.
That FMT will favorably change humoral function.
That FMT will favorably influence short-term clinical and radiological endpoints.

FMP30 donor stool will be obtained from OpenBiome (Somerville, Massachusetts; OpenBiome.org), an established nonprofit stool bank with stringent safety protocols and quality control. Donor stool will be obtained from donors without Multiple Sclerosis (MS) and without other known autoimmune diseases and will be screened for transmissible pathogens. In collaboration with OpenBiome, University of California, San Francisco (UCSF) will additionally screen donor stool using in vitro assays for immunological properties thought to be favorable in Multiple Sclerosis (MS), including decreasing T helper 17 cells (TH17) and increasing T regulatory cells, in order to select the final donor stool to be used in this study for FMT. UCSF will obtain an investigational new drug (IND) from the FDA for FMT of FMP30 donor stool in MS.

After providing written informed consent and reviewing inclusion and exclusion criteria, participants will participate in either the FMT Treatment Arm or the Observational Control Arm.

Participants in the FMT Treatment Arm will first undergo screening assessments according to the study schedule of activities and provide blood samples for eligibility and research, and stool samples for research. Participants who pass screening will have their pre-treatment baseline visit with 21 days of their screening visit where they will have an MRI, safety and biomarker research blood sample collection, stool sample collection for research, complete study activities according to the study visit schedule, be given antibiotics, bowel preparation, a medication compliance diary and directions on when and how to start the antibiotics and bowel preparation before their scheduled FMT colonoscopy procedure.

The week before their Baseline FMT visit, participants will be contacted by study staff to initiate an oral antibiotic regimen for 5 days to precondition the gut for FMT and optimize engraftment of the donor microbiome. Study staff will ensure that the participants understand how to complete their oral antibiotic regimen, compliance diary, and bowel preparation correctly.

At the study Baseline Visit, following standard bowel preparation for colonoscopy, participants will then undergo colonoscopy with FMT of FMP30 by an experienced gastroenterologist. Participants will return for scheduled assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and follow-up MRI for 12 weeks, with additional safety and biomarker blood sample collection, and followed at weeks 24, 36, and 48. The active study time of 12 weeks was designed to be short to minimize time off MS disease-modifying therapies (should the participant wish to go on a MS disease-modifying therapy).

Participants participating in the Observational Control Arm will not undergo the interventional FMT treatment. Participants in this arm will have a total of 5 visits over the course of 12 weeks. At the Screening/Baseline visit, participants will provide blood and stool samples for research along with other study activities, according to the study visit schedule. Participants will mail in a stool sample at week 2 and come in for follow-up visits at weeks 4, 8, and 12.

Conditions: Relapsing Remitting Multiple Sclerosis
Being tested: FMP30 Donor Stool, Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool, Observational Control
Keywords: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fecal Microbiota Transplantation
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FMP30 Donor StoolDrug
FMP30 is manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
Fecal Microbiota Transplantation (FMT) of FMP30 Donor StoolProcedure or surgery
Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30), obtained from the non-profit stool bank OpenBiome, will be administered via colonoscopy in patients with Relapsing-Remitting Multiple Sclerosis. FMT dosage via colonoscopy may include a lower amount of transplanted stool at the discretion of the study gastroenterologist if there are any peri-procedural safety or technical considerations. Total FMT dose (in milliliters) will be documented.
Observational ControlOther
Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration, and prior use of allowable MS therapies will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.

Study groups in NCT03594487
Study group	Role	What they receive
Interventional FMT Treatment Arm	Experimental	After providing written informed consent, participants will undergo screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants will then initiate an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants will undergo the FMT procedure by an experienced gastroenterologist. Participants will return for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks. The active study time is designed to be short (12 weeks active phase) to minimize time off on other MS disease-modifying therapy (DMT). This arm of the study will last for approximately 52 weeks total (4 weeks of screening + 12 weeks active treatment phase + 36 weeks of safety follow-up). Receives: Drug: FMP30 Donor Stool; Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool
Observational Control Arm	Active comparator	Participants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration, and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures. After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection. The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco. Receives: Other: Observational Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants Who Complete the Study Protocol
This includes the proportion of participants who completed the study protocol, including the completion of the study visits at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and a safety follow-up through week 48.
Measured: Baseline through week 48
Change in Fecal Microbiota
Engraftment: Change in fecal microbiota community structure at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, 12 weeks by 16S ribosomal RNA amplicon sequencing (as a measure of the diversity of fecal microbiota by detecting sequence variations).
Comment on unit of measure: The Shannon Index is used to assess changes in fecal microbiota diversity, with higher values indicating greater microbial diversity. Changes in the Shannon index over time will reflect the impact of the intervention on gut microbial composition.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Number of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
Treatment-emergent serious adverse events from baseline through week 12. The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale for adverse events used in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Number of Treatment-Emergent Non-Serious Adverse Events [Safety and Tolerability]
Treatment-emergent non-serious adverse events from baseline through week 12. The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale for adverse events used in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

Secondary outcomes (12)

Change in Plasma CD19+ B Cells in Interventional Arm [CD19: Cluster of Differentiation Antigen 19]
Plasma CD19+ B cell count will be measured as absolute cell counts (cells/uL) at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Change in Plasma CD19+ B Cells in Observational Arm
Plasma CD19+ B cell count will be measured as absolute cell counts (cells/uL) at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Change in Serum IgA Immunoglobulin Levels in Interventional Arm [IgA: Immunoglobulin A]
Serum Immunoglobulin levels of IgA will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Change in Serum IgA Immunoglobulin Levels in Observational Arm
Serum Immunoglobulin levels of IgA will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, and 12 weeks.
Change in Serum IgM Immunoglobulin Levels in Interventional Arm [IgM: Immunoglobulin M]
Serum Immunoglobulin levels of IgM will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Change in Serum IgM Immunoglobulin Levels in Observational Arm
Serum Immunoglobulin levels of IgM will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The percentage of change from baseline for each time point is also reported.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Change in Serum IgG Immunoglobulin Levels in Interventional Arm [IgG: Immunoglobulin G]
Serum Immunoglobulin levels of IgG will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Change in Serum IgG Immunoglobulin Levels in Observational Arm
Serum Immunoglobulin levels of IgG will be measured in mg/dL at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Measured: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Incidence of New T2/FLAIR Lesions
The number of new or enlarging T2/FLAIR lesions will be counted at pre-treatment and week 12.
Measured: At pre-treatment visit and week 12.
Treatment-emergent Gadolinium Enhancing Lesions
New treatment-emergent gadolinium-enhancing lesions on brain MRI.
Measured: At pre-treatment visit and week 12.
Clinical Relapse
Clinical relapse through week 12 (treatment phase)
Measured: From baseline to week 12
Percentage of Induced T-regulatory Cells
Flow cytometric analysis of peripheral blood mononuclear cells (PBMC) from each participant and at each time point. T-regs were induced by stimulation of PBMCs with anti-CD3 and anti-CD28 antibodies in the presence of IL2 and TGFb. The percentage of T-regs before and after FMT was analyzed. FMT was performed during the baseline visit. [CD3: cluster of differentiation 3, CD28: cluster of differentiation 28, IL2: interleukin2, TGFb: Transforming growth factor beta]
Measured: Pre-screening, Screening, Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201816 Dec 2024

First posted20 Jul 2018
Study start16 Nov 2018
Primary completion16 Dec 2024
Study completion16 Dec 2024

Why it stopped: Under-enrollment, including after interruption due to a hold on source FMT material and the COVID-19 pandemic

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03594487
Sponsor's protocol ID: 17-23827
Acronym: MS-BIOME
Status last verified: Jan 2026
First submitted: 7 Jun 2018
Last updated: 3 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Outcome data as well as study data related to diagnosis, disease presentation, and date of birth, along with biological specimens collected as part of the study, may be shared (in coded form) in the future with other qualified researchers on a case by case basis at the discretion of the PI and Co-PIs. Any such investigator will be required to provide appropriate documentation that the research being conducted has been approved by an Institutional Review Board and demonstrate that it will be of value in determining the cause of MS or a related disorder, and as allowed by the UCSF Institutional Review Board.

Publications

Cekanaviciute E, Yoo BB, Runia TF, Debelius JW, Singh S, Nelson CA, Kanner R, Bencosme Y, Lee YK, Hauser SL, Crabtree-Hartman E, Sand IK, Gacias M, Zhu Y, Casaccia P, Cree BAC, Knight R, Mazmanian SK, Baranzini SE. Gut bacteria from multiple sclerosis patients modulate human T cells and exacerbate symptoms in mouse models. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10713-10718. doi: 10.1073/pnas.1711235114. Epub 2017 Sep 11.
PubMed 28893978
Bafeta A, Yavchitz A, Riveros C, Batista R, Ravaud P. Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review. Ann Intern Med. 2017 Jul 4;167(1):34-39. doi: 10.7326/M16-2810. Epub 2017 May 23.
PubMed 28531908
Morris MS, Graham LA, Chu DI, Cannon JA, Hawn MT. Oral Antibiotic Bowel Preparation Significantly Reduces Surgical Site Infection Rates and Readmission Rates in Elective Colorectal Surgery. Ann Surg. 2015 Jun;261(6):1034-40. doi: 10.1097/SLA.0000000000001125.
PubMed 25607761
Tremlett H, Fadrosh DW, Faruqi AA, Hart J, Roalstad S, Graves J, Lynch S, Waubant E; US Network of Pediatric MS Centers. Gut microbiota composition and relapse risk in pediatric MS: A pilot study. J Neurol Sci. 2016 Apr 15;363:153-7. doi: 10.1016/j.jns.2016.02.042. Epub 2016 Feb 20.
PubMed 27000242
Ochoa-Reparaz J, Magori K, Kasper LH. The chicken or the egg dilemma: intestinal dysbiosis in multiple sclerosis. Ann Transl Med. 2017 Mar;5(6):145. doi: 10.21037/atm.2017.01.18.
PubMed 28462225
Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.
PubMed 24018052
Jangi S, Gandhi R, Cox LM, Li N, von Glehn F, Yan R, Patel B, Mazzola MA, Liu S, Glanz BL, Cook S, Tankou S, Stuart F, Melo K, Nejad P, Smith K, Topcuolu BD, Holden J, Kivisakk P, Chitnis T, De Jager PL, Quintana FJ, Gerber GK, Bry L, Weiner HL. Alterations of the human gut microbiome in multiple sclerosis. Nat Commun. 2016 Jun 28;7:12015. doi: 10.1038/ncomms12015.
PubMed 27352007
Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.
PubMed 26757463
Uygun A, Ozturk K, Demirci H, Oger C, Avci IY, Turker T, Gulsen M. Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. Medicine (Baltimore). 2017 Apr;96(16):e6479. doi: 10.1097/MD.0000000000006479.
PubMed 28422836
Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 30.
PubMed 28586116

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune Function
ClinicalTrials.gov ID: NCT03594487
Acronym / sponsor ID: MS-BIOME / 17-23827
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Fecal Microbiota Transplantation
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Under-enrollment, including after interruption due to a hold on source FMT material and the COVID-19 pandemic
Enrolment: 5 participants (actual)
Lead sponsor: Jeffrey GelfandUniversity, hospital or other
Study start: 16 Nov 2018 (actual)
Primary completion: 16 Dec 2024 (actual)
Study completion: 16 Dec 2024 (actual)
First posted: 20 Jul 2018 (actual)
Results: Posted 3 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In this Phase 1b open-label prospective clinical trial, patients with relapsing- remitting MS will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints will be assessed at various time points. The active phase of the study will continue for 12 weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel observational control arm of MS patients who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.

The primary hypotheses are that:

FMT will be safe and tolerable in patients with MS.
FMT preceded by antibiotic preconditioning will lead to a change in fecal microbiota community structure.

Secondary hypotheses are that:

FMT preceded by antibiotic preconditioning will induce a favorable shift from pro-inflammatory to immunomodulatory T cell profiles in patients with relapsing-remitting MS.
That engraftment will not appreciably decay over time.
That FMT will favorably change humoral function.
That FMT will favorably influence short-term clinical and radiological endpoints.

After providing written informed consent and reviewing inclusion and exclusion criteria, participants will participate in either the FMT Treatment Arm or the Observational Control Arm.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Interventional FMT Treatment Arm	Experimental	Drug: FMP30 Donor Stool, Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor StoolAfter providing written informed consent, participants will undergo screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Participants will then initiate an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, participants will undergo the FMT procedure by an experienced gastroenterologist. Participants will return for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks. The active study time is designed to be short (12 weeks active phase) to minimize time off on other MS disease-modifying therapy (DMT). This arm of the study will last for approximately 52 weeks total (4 weeks of screening + 12 weeks active treatment phase + 36 weeks of safety follow-up).
Observational Control Arm	Active comparator	Other: Observational ControlParticipants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration, and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures. After providing written informed consent, participants will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, participants will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection. The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Age 18-60 inclusive (at time of screening).
Diagnosis of relapsing-remitting multiple sclerosis (MS) by the International Panel McDonald Criteria (2010)(1), incorporating 2017 revisions, which reclassify select high-risk Clinically Isolated Syndromes under 2010 criteria as RRMS under 2017 criteria, and Lublin criteria (2014)(2). [RRMS: relapsing remitting multiple sclerosis]
Recent documented MS disease activity, defined as at least 1 clinical relapse within the past 1 year prior to baseline OR 2 clinical relapses in the past 2 years prior to baseline OR at least 1 new T2/FLAIR lesion on brain or spine MRI OR at least 1 gadolinium enhancing lesion on brain or spine MRI in the past 1 year prior to baseline.
Expanded Disability Status Scale (EDSS) less than or equal to 6.0; EDSS 5.5 or less if MS disease duration is greater than 15 years (no other disease duration restriction).
Must have positive serology for Epstein-Barr Virus (EBV) (IgG anti-EBNA positive) at screening, indicating prior exposure. [EBNA: Epstein-Barr nuclear antigen]

Key exclusion criteria (16 listed)

Prior use of fingolimod, dimethyl fumarate, teriflunomide, natalizumab, alemtuzumab, mitoxantrone, cyclophosphamide, rituximab, ocrelizumab, daclizumab, methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, leflunomide, or induction chemotherapy.
No use of diuretics like furosemide (Lasix) 1 week before the first dose of oral antibiotics. The use of hydrochlorothiazide (HCTZ) for hypertension at a dose < 50 mg/day is allowable.
Progressive MS by Lublin criteria (2014).
No oral or IV antibiotics are allowed within 8 weeks prior to screening and within 12 weeks prior to the planned FMT procedure (for participants in the FMT arm) or prior to the first stool collection (for participants in the control arm). (Note that topical, otic, ocular antibiotics are specifically allowable, which is consistent with the IMSMS.org protocol for collaborative gut microbiome research in MS). [IMSMS: International MS Microbiome Study]
Hypersensitivity or allergy to study antibiotics, conscious sedation medications, or bowel preparation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FMP30 Donor StoolFMP30 is manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.	Drug	Interventional FMT Treatment Arm
Fecal Microbiota Transplantation (FMT) of FMP30 Donor StoolThree doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30), obtained from the non-profit stool bank OpenBiome, will be administered via colonoscopy in patients with Relapsing-Remitting Multiple Sclerosis. FMT dosage via colonoscopy may include a lower amount of transplanted stool at the discretion of the study gastroenterologist if there are any peri-procedural safety or technical considerations. Total FMT dose (in milliliters) will be documented.	Procedure or surgery	Interventional FMT Treatment Arm
Observational ControlParticipants, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration, and prior use of allowable MS therapies will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.	Other	Observational Control Arm

Primary outcome

Participants Who Complete the Study Protocol
Time frame: Baseline through week 48
This includes the proportion of participants who completed the study protocol, including the completion of the study visits at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and a safety follow-up through week 48.
Change in Fecal Microbiota
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Engraftment: Change in fecal microbiota community structure at Baseline Visit, 2 weeks, 4 weeks, 8 weeks, 12 weeks by 16S ribosomal RNA amplicon sequencing (as a measure of the diversity of fecal microbiota by detecting sequence variations). Comment on unit of measure: The Shannon Index is used to assess changes in fecal microbiota diversity, with higher values indicating greater microbial diversity. Changes in the Shannon index over time will reflect the impact of the intervention on gut microbial composition.
Number of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Treatment-emergent serious adverse events from baseline through week 12. The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale for adverse events used in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.
Number of Treatment-Emergent Non-Serious Adverse Events [Safety and Tolerability]
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Treatment-emergent non-serious adverse events from baseline through week 12. The proportion of participants who develop an adverse event (AE) of severity grade 2 or more by NIH CTCAE criteria V4.0 is considered serious. NIH CTCAE is a standardized classification and severity grading scale for adverse events used in clinical trials. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Grade 1 is considered mild, Grade 2 as moderate, Grade 3 as severe or medically significant, Grade 4 as life-threatening, and Grade 5 as death related to AE.

12 secondary outcomes

Change in Plasma CD19+ B Cells in Interventional Arm [CD19: Cluster of Differentiation Antigen 19]
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Change in Plasma CD19+ B Cells in Observational Arm
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Change in Serum IgA Immunoglobulin Levels in Interventional Arm [IgA: Immunoglobulin A]
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
Change in Serum IgA Immunoglobulin Levels in Observational Arm
Time frame: Baseline Visit, 2 weeks, 4 weeks, and 12 weeks.
Change in Serum IgM Immunoglobulin Levels in Interventional Arm [IgM: Immunoglobulin M]
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Change in Serum IgM Immunoglobulin Levels in Observational Arm
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Change in Serum IgG Immunoglobulin Levels in Interventional Arm [IgG: Immunoglobulin G]
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Change in Serum IgG Immunoglobulin Levels in Observational Arm
Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks and 12 weeks
Incidence of New T2/FLAIR Lesions
Time frame: At pre-treatment visit and week 12.
Treatment-emergent Gadolinium Enhancing Lesions
Time frame: At pre-treatment visit and week 12.
Clinical Relapse
Time frame: From baseline to week 12
Percentage of Induced T-regulatory Cells
Time frame: Pre-screening, Screening, Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Results and safety

Results posted to the registry on 3 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interventional FMT Treatment Arm	4	4
Observational Control Arm	1	1

Primary outcome: Participants Who Complete the Study Protocol

Time frame: Baseline through week 48. Count of participants. Unit: Participants

Measure	Interventional FMT Treatment Arm n = 4	Observational Control Arm n = 1
Value	4	1

Population analysed: All enrolled participants who received FMT completed the study protocol; however, the study was interrupted due to the COVID-19 pandemic and a hold on the source material, and was subsequently closed to further enrollment.

Primary outcome: Change in Fecal Microbiota

Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.. Number. Unit: Shannon index

Measure	Change in Microbiota Structure at Baseline in FMT Treatment Arm n = 4	Change in Microbiota Structure at Week 2 in FMT Treatment Arm n = 4	Change in Microbiota Structure at Week 4 in FMT Treatment Arm n = 4	Change in Microbiota Structure at Week 8 in FMT Treatment Arm n = 4	Change in Microbiota Structure at Week 12 in FMT Treatment Arm n = 4
Participant 1	0.87	4.60	4.10	4.50	4.10
Participant 2	1.10	5.78	5.70	5.80	5.85
Participant 3	5.10	5.60	5.15	5.18	5.20
Participant 4	2.35	3.90	3.85	3.95	3.80

Population analysed: No samples were collected for the control participant at any of the time points ( Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks) as the study was interrupted due to COVID-19. We don't have data to report for the change in microbiota structure for the control participant, who did not receive an intervention. This data will also not be reported in the future (as it was not collected).

Primary outcome: Number of Treatment-Emergent Serious Adverse Events [Safety and Tolerability]

Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.. Number. Unit: number of events

Measure	Number of Serious AE at Baseline n = 5	Number of Serious AE at Week 2 n = 5	Number of Serious AE at Week 4 n = 5	Number of Serious AE at Week 8 n = 5	Number of Serious AE at Week 12 n = 5
Interventional arm	0	0	0	0	0
Observational arm	0	0	0	0	0

Population analysed: All participants were monitored for the number of treatment-emergent serious adverse events from baseline through week 12.

Primary outcome: Number of Treatment-Emergent Non-Serious Adverse Events [Safety and Tolerability]

Time frame: Baseline Visit, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.. Number. Unit: Number of events

Measure	Number of Non-serious AE at Baseline n = 5	Number of Non-serious AE at Week 2 n = 5	Number of Non-serious AE at Week 4 n = 5	Number of Non-serious AE at Week 8 n = 5	Number of Non-serious AE at Week 12 n = 5
Interventional arm	1	0	0	0	0
Observational arm	0	0	0	0	0

Population analysed: All participants were monitored for the number of treatment-emergent non-serious adverse events from baseline through week 12.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12-week treatment phase (FMT) and 36-week safety follow-up for the interventional arm, and 12 weeks for the observational arm.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Number of Events at 12 Weeks for Interventional FMT Treatment Arm	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Number of Events at 36 Weeks for Interventional FMT Treatment Arm	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Number of Events at 12 Weeks for Observational Control Arm	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): The study was not fully recruited. Study recruitment was interrupted by both the COVID-19 pandemic and a hold on the FMT source material. Participants recruited up until that point were analyzed with available safety and outcome data reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28893978Cekanaviciute E, Yoo BB, Runia TF, Debelius JW, Singh S, Nelson CA, Kanner R, Bencosme Y, Lee YK, Hauser SL, Crabtree-Hartman E, Sand IK, Gacias M, Zhu Y, Casaccia P, Cree BAC, Knight R, Mazmanian SK, Baranzini SE. Gut bacteria from multiple sclerosis patients modulate human T cells and exacerbate symptoms in mouse models. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10713-10718. doi: 10.1073/pnas.1711235114. Epub 2017 Sep 11.
Background: PubMed 28531908Bafeta A, Yavchitz A, Riveros C, Batista R, Ravaud P. Methods and Reporting Studies Assessing Fecal Microbiota Transplantation: A Systematic Review. Ann Intern Med. 2017 Jul 4;167(1):34-39. doi: 10.7326/M16-2810. Epub 2017 May 23.
Background: PubMed 25607761Morris MS, Graham LA, Chu DI, Cannon JA, Hawn MT. Oral Antibiotic Bowel Preparation Significantly Reduces Surgical Site Infection Rates and Readmission Rates in Elective Colorectal Surgery. Ann Surg. 2015 Jun;261(6):1034-40. doi: 10.1097/SLA.0000000000001125.
Background: PubMed 27000242Tremlett H, Fadrosh DW, Faruqi AA, Hart J, Roalstad S, Graves J, Lynch S, Waubant E; US Network of Pediatric MS Centers. Gut microbiota composition and relapse risk in pediatric MS: A pilot study. J Neurol Sci. 2016 Apr 15;363:153-7. doi: 10.1016/j.jns.2016.02.042. Epub 2016 Feb 20.
Background: PubMed 28462225Ochoa-Reparaz J, Magori K, Kasper LH. The chicken or the egg dilemma: intestinal dysbiosis in multiple sclerosis. Ann Transl Med. 2017 Mar;5(6):145. doi: 10.21037/atm.2017.01.18.
Background: PubMed 24018052Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.
Background: PubMed 27352007Jangi S, Gandhi R, Cox LM, Li N, von Glehn F, Yan R, Patel B, Mazzola MA, Liu S, Glanz BL, Cook S, Tankou S, Stuart F, Melo K, Nejad P, Smith K, Topcuolu BD, Holden J, Kivisakk P, Chitnis T, De Jager PL, Quintana FJ, Gerber GK, Bry L, Weiner HL. Alterations of the human gut microbiome in multiple sclerosis. Nat Commun. 2016 Jun 28;7:12015. doi: 10.1038/ncomms12015.
Background: PubMed 26757463Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.
Background: PubMed 28422836Uygun A, Ozturk K, Demirci H, Oger C, Avci IY, Turker T, Gulsen M. Fecal microbiota transplantation is a rescue treatment modality for refractory ulcerative colitis. Medicine (Baltimore). 2017 Apr;96(16):e6479. doi: 10.1097/MD.0000000000006479.
Background: PubMed 28586116Bajaj JS, Kassam Z, Fagan A, Gavis EA, Liu E, Cox IJ, Kheradman R, Heuman D, Wang J, Gurry T, Williams R, Sikaroodi M, Fuchs M, Alm E, John B, Thacker LR, Riva A, Smith M, Taylor-Robinson SD, Gillevet PM. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial. Hepatology. 2017 Dec;66(6):1727-1738. doi: 10.1002/hep.29306. Epub 2017 Oct 30.
Individual participant dataSharing planned: Yes. Outcome data as well as study data related to diagnosis, disease presentation, and date of birth, along with biological specimens collected as part of the study, may be shared (in coded form) in the future with other qualified researchers on a case by case basis at the discretion of the PI and Co-PIs. Any such investigator will be required to provide appropriate documentation that the research being conducted has been approved by an Institutional Review Board and demonstrate that it will be of value in determining the cause of MS or a related disorder, and as allowed by the UCSF Institutional Review Board.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Gelfand, MD, MAS principal investigator

UCSF Multiple Sclerosis Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants Who Complete the Study Protocol (time frame: Baseline through week 48). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03594487, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.