Gastro-Intestinal DisorderPhase 1NCT05664113
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
A Phase 1 study testing Fecal microbiota transplant (FMT) in people with Gastro-Intestinal Disorder, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT). Primary Objective To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Gastro-Intestinal Disorder
- What is being tested?
- Fecal microbiota transplant (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Up to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 22 years old.
- Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
- Diagnosed with one of the following conditions:
- Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, >/= 1mg/kg of prednisolone) OR
- Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment).
- OR
Show all 11Show fewer
- Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools >/= 4 weeks with at least one of the following:
- Requiring NG or G-tube feeds
- Requiring TPN or IVF for more than 4 weeks
- Diagnosis of gastroparesis by GI specialist documented in the medical record
- Willing and able to provide informed assent/consent
Who cannot join
- Participant is at risk for aspiration pneumonia
- History of anaphylactic allergy to foods that are not excluded from the stool donor diet
- Female participant who is pregnant or nursing
- History of previous FMT
- Intra-abdominal surgery within 4 weeks of enrollment
- At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites
- Concurrent abdominal radiation therapy
- Any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Gabriela Maron, MD, 888-226-4343, referralinfo@stjude.org
About this study
The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT).
Primary Objective
- To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT.
- To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction.
Secondary Objectives
- To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT.
- To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.
Read the detailed description
Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT
- Conditions
- Gastro-Intestinal Disorder
- Being tested
- Fecal microbiota transplant (FMT)
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplant (FMT)Drug
Also called FMT
FMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube
| Study group | Role | What they receive |
|---|---|---|
| Stratum A | Experimental | Diagnosed with GvHD Receives: Drug: Fecal microbiota transplant (FMT) |
| Stratum B | Experimental | GI Dysfunction Receives: Drug: Fecal microbiota transplant (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a serious adverse event occurring within 30 days following FMT
Serious adverse events will be a primary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 30 Days
Proportion of participants with a non-serious adverse event occurring within 30 days following FMT
Non-serious adverse events will be a primary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 30 Days
Proportion of participants expressing interest who meet eligibility
Participant eligibility will be a primary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 2 years
Proportion of participants recruited in the eligible population
Participant recruitment will be a primary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 2 years
Proportion of participants that drop up post-enrollment
Participant retention will be a primary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 3 years
Proportion of participants providing all protocol required stool samples
Stool specimens will be a primary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 3 years
Secondary outcomes (2)
Proportion of participants with a complete response or a partial response
Complete response or partial response will be a secondary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 180 days
Percentage of participants who reduce or discontinue steroids at the end of the study
Reduction in dose of steroids will be a secondary outcome measure for the following groups:
- FMT for treating a GvHD of the gut following HCT
- FMT for treating HCT induced gut dysfunction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start7 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriela Maron, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664113
- Sponsor's protocol ID
- NEWGUT
- Other IDs
- NCI-2024-02553
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2022
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).
- ClinicalTrials.gov ID
- NCT05664113
- Acronym / sponsor ID
- NEWGUT
- Conditions
- Gastro-Intestinal Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Dec 2022 (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.
The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT).
Primary Objective
- To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT.
- To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction.
Secondary Objectives
- To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT.
- To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.
Detailed description
Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stratum A | Experimental | Drug: Fecal microbiota transplant (FMT)Diagnosed with GvHD |
| Stratum B | Experimental | Drug: Fecal microbiota transplant (FMT)GI Dysfunction |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Age < 22 years old.
- Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
- Diagnosed with one of the following conditions:
- OR
- Willing and able to provide informed assent/consent
Key exclusion criteria (8 listed)
- Participant is at risk for aspiration pneumonia
- History of anaphylactic allergy to foods that are not excluded from the stool donor diet
- Female participant who is pregnant or nursing
- History of previous FMT
- Intra-abdominal surgery within 4 weeks of enrollment
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 transplant (FMT)Also: FMTFMT Lower Delivery Microbiota Preparation, Dose: 250 mL of Microbiota Preparation Material and Route of administration: colonoscopy FMT Upper Delivery Microbiota Preparation, Dose: 60 mL of Microbiota Preparation Material and Route of administration: Naso-enteral tube | Drug | Stratum A, Stratum B |
Primary outcome
Proportion of participants with a serious adverse event occurring within 30 days following FMT
Time frame: 30 Days
Serious adverse events will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
Proportion of participants with a non-serious adverse event occurring within 30 days following FMT
Time frame: 30 Days
Non-serious adverse events will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
Proportion of participants expressing interest who meet eligibility
Time frame: 2 years
Participant eligibility will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
Proportion of participants recruited in the eligible population
Time frame: 2 years
Participant recruitment will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
Proportion of participants that drop up post-enrollment
Time frame: 3 years
Participant retention will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
Proportion of participants providing all protocol required stool samples
Time frame: 3 years
Stool specimens will be a primary outcome measure for the following groups: * FMT for treating a GvHD of the gut following HCT * FMT for treating HCT induced gut dysfunction
2 secondary outcomes
Proportion of participants with a complete response or a partial response
Time frame: 180 days
Percentage of participants who reduce or discontinue steroids at the end of the study
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
Gabriela Maron, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal microbiota transplant (FMT) in people with Gastro-Intestinal Disorder, run by St. Jude Children's Research Hospital 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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 20 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Maron, MD (888-226-4343, referrainfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a serious adverse event occurring within 30 days following FMT (time frame: 30 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.