Multiple Sclerosis, Relapsing-RemittingNCT03975413

Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis

An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Multiple sclerosis (MS) is a chronic immune central nervous system (CNS) disease of unknown cause. Recent studies suggest that gut microbiota could be a trigger for the neuro-inflammation in MS and abnormal gut microbiota composition has been reported in MS patients. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Multiple Sclerosis, Relapsing-Remitting
What is being tested?: Fecal Microbiota Transplantation (FMT)
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2018to 1 May 2020
Phase: Observational
Are there results?: None posted in the registry

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: One of the investigators' patients planned to have a fecal microbiota transplant (FMT) for treatment of their MS, at the Taymount Clinic in the Bahamas, volunteered to donate multiple sample collection time points for stool and blood. Additionally, the subject would undergo gait metric activity and MRI (brain \& spine), as well as completing MS rating scales and various GI, diet and sleep clinical questionnaires.

Who may be able to join

Older than 18 years of age.
Diagnosis of relapsing-remitting multiple sclerosis (RRMS) by neurology(primary specialist).
Presence of active lesions on brain or spinal cord MRI, in the past 1 year prior to baseline.
MS disease duration greater than 1 year.
Symptomatic (Active RRMS).
On MS therapy/medication greater than 4 weeks.

Who cannot join

Newly diagnosed multiple sclerosis.
Inactive relapsing-remitting multiple sclerosis (RRMS).
Unstable or no MS therapy/medication use.
Presence of symptomatically active gastrointestinal diseases such as inflammatory bowel disease or celiac disease (except for hemorrhoids, hiatal hernia, or occasional (˂3 times a week) heartburn)).
Pre-existent organ failure or co-morbidities as these may change GI flora: a) liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X˃ normal); b) kidney disease (creatinine ˃ 2.0mg/dL); c) uncontrolled psychiatric illness; d) clinically active lung disease or decompensated heart failure; e) known HIV infection; f) alcoholism; g) transplant recipients (other than FMT); h) diabetes
Severe malnutrition or obesity with BMI ˃ 40.

Show all 12Show fewer

Antibiotic and probiotic use (except yogurt) within 4 weeks of enrollment.
Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rush University Medical Center
Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Single-Arm, Non-Randomized, Time Series, Single-Subject Study: Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis

Read the detailed description

A subject (n-of-1) clinically diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS), by Rush University Neurologists, volunteered and provided written informed consent to participate in this study conducted by Rush University Medical Center's department of Digestive Diseases and Nutrition. The RRMS subject underwent a fecal microbiota transplantation (FMT) administered outside the United States, at Taymount Clinic in the Bahamas, for the treatment of their MS. Being one of the investigators' patients, the subject volunteered to donate their stool samples to the Rush University Medical Center Gastrointestinal (GI) tissue repository for microbiota interrogation at the following time points: before FMT (baseline), 3, 13, 26, 39, 52 weeks (1 year) after FMT, to determine the impact on their microbiota composition and sustainability of the change. The subject also agreed to donate their blood during the above stated time points to see if FMT affected markers of bacteria translocation and systemic inflammation. The subject also agreed to have their GI symptoms, diet, sleep, and MS related symptoms (rating scales or questionnaires), MRI (brain \& spine), as well as their gait metric activity objectively assessed to see if the FMT affects these symptoms and whether any observed improvement is sustained, in this proof-of-concept study. Based on this research, the investigators hypothesize that the FMT will significantly altered the overall microbial community structure to promote the growth of short chain fatty acid (SCFA)-producing beneficial bacteria, which in turn could potentially improve the MS subject's health outcomes, neurological symptoms, and walking metrics over time. More clinical trials (larger sample size) will be needed to study the potential of FMT for the treatment of MS and to examine the long term effects. FMT is an emerging treatment approach for MS. The donor selection, the separation of fecal bacteria, the frequency of FMT, the way of infusion, the long-term safety, and efficacy are still uncertain and need to be examined.

Conditions: Multiple Sclerosis, Relapsing-Remitting
Being tested: Fecal Microbiota Transplantation (FMT)
Keywords: FMT, Microbiome, Gait, Longitudinal, Multiple Sclerosis
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.

Fecal Microbiota Transplantation (FMT)Other
Also called Taymount Clinic
Longitudinal FMT study: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week

Study groups in NCT03975413
Study group	Role	What they receive
N=1 MS patient		Single-Arm, Non-Randomized, Time Series, Single-Subject Study. Observational study of the FMT intervention. Single subject studies are based on repeated observations within an individual over time and are acknowledged as an important research method for generating scientific evidence about the health or behavior of an individual. This design is desirable when the available patient pool is limited and thus it is not optimal to randomize participants to a control arm. The subject serves as his/her own control, rather than using another individual/group.These designs are used primarily to evaluate the effect of a variety of interventions in early stage clinical research development. Receives: Other: Fecal Microbiota Transplantation (FMT)

What is being measured

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

Fecal microbial community structure and functional changes over six time frames for phylum, genus and species taxonomic level bacteria, virus, fungi, and archaea.
Shotgun Metagenomics
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Walking and balance changes over four time frames for stride time (seconds).
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Measured: Baseline, 3 week, 13 week, 52 week
Walking and balance changes over four time frames for stride distance (meters).
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Measured: Baseline, 3 week, 13 week, 52 week
Walking and balance changes over four time frames for cadence (total number of steps per minute).
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Measured: Baseline, 3 week, 13 week, 52 week
Walking and balance changes over four time frames for step width (meters).
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Measured: Baseline, 3 week, 13 week, 52 week
Walking and balance changes over four time frames for average pelvis forward velocity (meters per second).
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Measured: Baseline, 3 week, 13 week, 52 week
Walking and balance changes over four time frames for pelvis smoothness (pelvis horizontal speed).
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Measured: Baseline, 3 week, 13 week, 52 week

Secondary outcomes (13)

Fecal targeted short-chain-fatty-acid metabolomics concentration changes over six time frames for acetate (mM/kg), propionate (mM/kg), butyrate (mM/kg), and total SCFA (mM/kg).
Targeted metabolomics of short-chain-fatty-acids (SCFA).
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker brain-derived neurotrophic factor (BDNF) (ng/ml) changes over six time frames.
ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Sleep changes over six time frames.
Munich ChronoType Questionnaire (MCTQ). Questions about work day and free day sleep schedules, work details, and lifestyle provide data to aid in the understanding of how biological clocks work in social life, such as Roenneberg's conclusions of social jetlag. The MCTQ categorizes each participant into one of seven chronotype groups, and utilizes data on participants' midsleep phase and sleep debt to survey what "type" of sleeper each person is.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Food timing changes over six time frames.
Food Timing Screener (FTS) questionnaire. A structured food demographics questionnaire was therefore developed to access food timing. The questionnaire consists of eight questions asking subjects' eating habits on work days and non-work days. Questions include the time of the main meal during work and non-work days, time of last meal before bed, consistency of dinner within work and non-work days, and consistency of breakfast, lunch, and dinner between work and non-work days.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Gastrointestinal symptoms changes over six time frames (t-scores, mean, standard deviations).
Patient-Reported Outcomes Measurements Information System (PROMIS) gastrointestinal questionnaire for Belly Pain (6 questions), Bowel Incontinence (4 questions), Constipation (9 questions), and Gas \& Bloating (12 questions). Higher score denoted more GI symptoms. Lower score denotes less GI symptoms. Scores range from 20 (low) to 80 (high). A score of 50 is denoted as the general population.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Walking changes over six time frames.
Multiple sclerosis walking scale questionnaire. Higher scores indicate a greater impact from MS on walking than lower scores. Scale range from 1 (no impact) to 5 (high impact). 12 questions in total.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Lesions changes over three time frames.
MRI of brain and spine
Measured: Baseline, 26 week and 52 week
Food and frequency of consumption changes over six time frames.
Food Time Questionnaire (FTQ) consists of a list of foods and the frequency in which these foods are consumed in at each time frame.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Single day food recall changes over six time frames.
Automated Self-Administered 24-Hour Recall (ASA24) Dietary Assessment. Total nutrients from all supplements reported in a given day.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Diet changes over six time frames.
Vioscreen Food Frequency Questionnaire (FFQ). Total of 19 measured food components collected for each time frame. Vioscreen captures comprehensive dietary behaviors in just 30 minutes. VioScreen is a unique online dietary questionnaire, management and analysis system that efficiently gathers and manages data, that immediately identify dietary "habits" and counsel for lifestyle changes.
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker Interleukin-6 (IL-6) (pg/ml) changes over six time frames.
ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker Interleukin-* (IL-8) (pg/ml) changes over six time frames.
ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker Tumor necrosis factor alpha (TNFα) (pg/ml) changes over six time frames.
ELISA (enzyme-linked immunosorbent assay)
Measured: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week

Timeline

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

25 Sep 20181 May 2020

First posted5 Jun 2019
Study start25 Sep 2018
Primary completion1 Apr 2020
Study completion1 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
More trials run by Rush University Medical CenterThe sponsor's other registered studies.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03975413
Sponsor's protocol ID: 18082009
Status last verified: Oct 2020
First submitted: 28 May 2019
Last updated: 8 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: It is not yet known if there will be a plan to make IPD available. This pilot study of FMT in a patient with multiple sclerosis (MS) could suggest a potential effective treatment. More clinical trials (larger sample size) will be needed to study the potential of FMT for the treatment of MS and it's long term effects in the future.

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
Berer K, Gerdes LA, Cekanaviciute E, Jia X, Xiao L, Xia Z, Liu C, Klotz L, Stauffer U, Baranzini SE, Kumpfel T, Hohlfeld R, Krishnamoorthy G, Wekerle H. Gut microbiota from multiple sclerosis patients enables spontaneous autoimmune encephalomyelitis in mice. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10719-10724. doi: 10.1073/pnas.1711233114. Epub 2017 Sep 11.
PubMed 28893994
Kaskow BJ, Baecher-Allan C. Effector T Cells in Multiple Sclerosis. Cold Spring Harb Perspect Med. 2018 Apr 2;8(4):a029025. doi: 10.1101/cshperspect.a029025.
PubMed 29358315
Berer K, Mues M, Koutrolos M, Rasbi ZA, Boziki M, Johner C, Wekerle H, Krishnamoorthy G. Commensal microbiota and myelin autoantigen cooperate to trigger autoimmune demyelination. Nature. 2011 Oct 26;479(7374):538-41. doi: 10.1038/nature10554.
PubMed 22031325
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
Kirby TO, Ochoa-Reparaz J. The Gut Microbiome in Multiple Sclerosis: A Potential Therapeutic Avenue. Med Sci (Basel). 2018 Aug 24;6(3):69. doi: 10.3390/medsci6030069.
PubMed 30149548
Adamczyk-Sowa M, Medrek A, Madej P, Michlicka W, Dobrakowski P. Does the Gut Microbiota Influence Immunity and Inflammation in Multiple Sclerosis Pathophysiology? J Immunol Res. 2017;2017:7904821. doi: 10.1155/2017/7904821. Epub 2017 Feb 20.
PubMed 28316999
Camara-Lemarroy CR, Metz LM, Yong VW. Focus on the gut-brain axis: Multiple sclerosis, the intestinal barrier and the microbiome. World J Gastroenterol. 2018 Oct 7;24(37):4217-4223. doi: 10.3748/wjg.v24.i37.4217.
PubMed 30310254
Makkawi S, Camara-Lemarroy C, Metz L. Fecal microbiota transplantation associated with 10 years of stability in a patient with SPMS. Neurol Neuroimmunol Neuroinflamm. 2018 Apr 3;5(4):e459. doi: 10.1212/NXI.0000000000000459. eCollection 2018 Jul. No abstract available.
PubMed 29619403
Quintana FJ, Prinz M. A gut feeling about multiple sclerosis. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10528-10529. doi: 10.1073/pnas.1714260114. Epub 2017 Sep 25. No abstract available.
PubMed 28973867
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
Chu F, Shi M, Lang Y, Shen D, Jin T, Zhu J, Cui L. Gut Microbiota in Multiple Sclerosis and Experimental Autoimmune Encephalomyelitis: Current Applications and Future Perspectives. Mediators Inflamm. 2018 Apr 2;2018:8168717. doi: 10.1155/2018/8168717. eCollection 2018.
PubMed 29805314
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
Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6.
PubMed 22674334

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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Arm, Non-Randomized, Time Series, Single-Subject Study: Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
ClinicalTrials.gov ID: NCT03975413
Acronym / sponsor ID: 18082009
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: FMT, Microbiome, Gait, Longitudinal, Multiple Sclerosis
Study type: Observational
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Rush University Medical CenterUniversity, hospital or other
Study start: 25 Sep 2018 (actual)
Primary completion: 1 Apr 2020 (actual)
Study completion: 1 May 2020 (actual)
First posted: 5 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
N=1 MS patient	–	Other: Fecal Microbiota Transplantation (FMT)Single-Arm, Non-Randomized, Time Series, Single-Subject Study. Observational study of the FMT intervention. Single subject studies are based on repeated observations within an individual over time and are acknowledged as an important research method for generating scientific evidence about the health or behavior of an individual. This design is desirable when the available patient pool is limited and thus it is not optimal to randomize participants to a control arm. The subject serves as his/her own control, rather than using another individual/group.These designs are used primarily to evaluate the effect of a variety of interventions in early stage clinical research development.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: One of the investigators' patients planned to have a fecal microbiota transplant (FMT) for treatment of their MS, at the Taymount Clinic in the Bahamas, volunteered to donate multiple sample collection time points for stool and blood. Additionally, the subject would undergo gait metric activity and MRI (brain \& spine), as well as completing MS rating scales and various GI, diet and sleep clinical questionnaires.

Key inclusion criteria (6 listed)

Older than 18 years of age.
Diagnosis of relapsing-remitting multiple sclerosis (RRMS) by neurology(primary specialist).
Presence of active lesions on brain or spinal cord MRI, in the past 1 year prior to baseline.
MS disease duration greater than 1 year.
Symptomatic (Active RRMS).

Key exclusion criteria (12 listed)

Newly diagnosed multiple sclerosis.
Inactive relapsing-remitting multiple sclerosis (RRMS).
Unstable or no MS therapy/medication use.
Presence of symptomatically active gastrointestinal diseases such as inflammatory bowel disease or celiac disease (except for hemorrhoids, hiatal hernia, or occasional (˂3 times a week) heartburn)).
Pre-existent organ failure or co-morbidities as these may change GI flora: a) liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X˃ normal); b) kidney disease (creatinine ˃ 2.0mg/dL); c) uncontrolled psychiatric illness; d) clinically active lung disease or decompensated heart failure; e) known HIV infection; f) alcoholism; g) transplant recipients (other than FMT); h) diabetes

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
Fecal Microbiota Transplantation (FMT)Also: Taymount ClinicLongitudinal FMT study: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week	Other	N=1 MS patient

Primary outcome

Fecal microbial community structure and functional changes over six time frames for phylum, genus and species taxonomic level bacteria, virus, fungi, and archaea.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Shotgun Metagenomics
Walking and balance changes over four time frames for stride time (seconds).
Time frame: Baseline, 3 week, 13 week, 52 week
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Walking and balance changes over four time frames for stride distance (meters).
Time frame: Baseline, 3 week, 13 week, 52 week
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Walking and balance changes over four time frames for cadence (total number of steps per minute).
Time frame: Baseline, 3 week, 13 week, 52 week
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Walking and balance changes over four time frames for step width (meters).
Time frame: Baseline, 3 week, 13 week, 52 week
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Walking and balance changes over four time frames for average pelvis forward velocity (meters per second).
Time frame: Baseline, 3 week, 13 week, 52 week
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.
Walking and balance changes over four time frames for pelvis smoothness (pelvis horizontal speed).
Time frame: Baseline, 3 week, 13 week, 52 week
Orthopedic gait task, side gaze gait, and alternating gaze gait metrics.

13 secondary outcomes

Fecal targeted short-chain-fatty-acid metabolomics concentration changes over six time frames for acetate (mM/kg), propionate (mM/kg), butyrate (mM/kg), and total SCFA (mM/kg).
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker brain-derived neurotrophic factor (BDNF) (ng/ml) changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Sleep changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Food timing changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Gastrointestinal symptoms changes over six time frames (t-scores, mean, standard deviations).
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Walking changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Lesions changes over three time frames.
Time frame: Baseline, 26 week and 52 week
Food and frequency of consumption changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Single day food recall changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Diet changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker Interleukin-6 (IL-6) (pg/ml) changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker Interleukin-* (IL-8) (pg/ml) changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
Measurement of blood serum biomarker Tumor necrosis factor alpha (TNFα) (pg/ml) changes over six time frames.
Time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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 28893994Berer K, Gerdes LA, Cekanaviciute E, Jia X, Xiao L, Xia Z, Liu C, Klotz L, Stauffer U, Baranzini SE, Kumpfel T, Hohlfeld R, Krishnamoorthy G, Wekerle H. Gut microbiota from multiple sclerosis patients enables spontaneous autoimmune encephalomyelitis in mice. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10719-10724. doi: 10.1073/pnas.1711233114. Epub 2017 Sep 11.
Background: PubMed 29358315Kaskow BJ, Baecher-Allan C. Effector T Cells in Multiple Sclerosis. Cold Spring Harb Perspect Med. 2018 Apr 2;8(4):a029025. doi: 10.1101/cshperspect.a029025.
Background: PubMed 22031325Berer K, Mues M, Koutrolos M, Rasbi ZA, Boziki M, Johner C, Wekerle H, Krishnamoorthy G. Commensal microbiota and myelin autoantigen cooperate to trigger autoimmune demyelination. Nature. 2011 Oct 26;479(7374):538-41. doi: 10.1038/nature10554.
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 30149548Kirby TO, Ochoa-Reparaz J. The Gut Microbiome in Multiple Sclerosis: A Potential Therapeutic Avenue. Med Sci (Basel). 2018 Aug 24;6(3):69. doi: 10.3390/medsci6030069.
Background: PubMed 28316999Adamczyk-Sowa M, Medrek A, Madej P, Michlicka W, Dobrakowski P. Does the Gut Microbiota Influence Immunity and Inflammation in Multiple Sclerosis Pathophysiology? J Immunol Res. 2017;2017:7904821. doi: 10.1155/2017/7904821. Epub 2017 Feb 20.
Background: PubMed 30310254Camara-Lemarroy CR, Metz LM, Yong VW. Focus on the gut-brain axis: Multiple sclerosis, the intestinal barrier and the microbiome. World J Gastroenterol. 2018 Oct 7;24(37):4217-4223. doi: 10.3748/wjg.v24.i37.4217.
Background: PubMed 29619403Makkawi S, Camara-Lemarroy C, Metz L. Fecal microbiota transplantation associated with 10 years of stability in a patient with SPMS. Neurol Neuroimmunol Neuroinflamm. 2018 Apr 3;5(4):e459. doi: 10.1212/NXI.0000000000000459. eCollection 2018 Jul. No abstract available.
Background: PubMed 28973867Quintana FJ, Prinz M. A gut feeling about multiple sclerosis. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10528-10529. doi: 10.1073/pnas.1714260114. Epub 2017 Sep 25. No abstract available.
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.
Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available. This pilot study of FMT in a patient with multiple sclerosis (MS) could suggest a potential effective treatment. More clinical trials (larger sample size) will be needed to study the potential of FMT for the treatment of MS and it's long term effects in the future.

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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.

Ali Keshavarzian, MD principal investigator

Rush University Medical Center

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

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, Relapsing-Remitting, run by Rush University Medical Center at 1 site in United States.

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 6 inclusion and 12 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: finished, as of the sponsor's last update on 8 Oct 2020. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Fecal microbial community structure and functional changes over six time frames for phylum, genus and species taxonomic level bacteria, virus, fungi, and archaea. (time frame: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week). The study lists 7 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 NCT03975413, which also lists 15 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 8 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.