Can a stool transplant soothe an inflamed pouch?
NCT ID NCT05829109
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial tests whether fecal microbiota transplant (FMT) — transferring stool from a healthy donor pouch into an inflamed one — can safely ease chronic pouchitis, a complication after ulcerative colitis surgery. Participants first take antibiotics and a bowel prep, then receive two FMT enemas a week apart. The study tracks safety and whether patients achieve clinical remission and endoscopic improvement by week 8.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fecal microbiota transplant (FMT) via enema, preceded by antibiotics and bowel prep
- What this could lead to
- If successful, this could offer a new way to treat chronic pouchitis by restoring a healthy gut microbiome, potentially reducing the need for long-term antibiotics.
- What could go wrong
- This is a very early, small trial (16 people), so results may not apply broadly. Risks include infection or reactions from the transplant, and the procedure may not work.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients age 18 or greater with UC who have undergone TPC with IPAA and have one of the following chronic pouchitis phenotypes, each defined as: * Chronic antibiotic dependent pouchitis: * The need for continuous antibiotic therapy (\>4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes, OR * Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 and a history of ≥4 antibiotic therapies in the last 12 months * Chronic antibiotic refractory pouchitis: * Active pouchitis with a modified Pouchitis Disease Activity Index (mPDAI) ≥5 with no response to antibiotics * Crohn's disease like pouch inflammation on biologic or small molecule therapy with persistent symptoms: * Pre-pouch ileal inflammation, strictures, and/or fistulae, AND * Active biologic or small molecule therapy, AND * Persistent symptoms with mPDAI clinical sub-score ≥ 2 Exclusion Criteria: Patients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded: * Allergy to vancomycin, metronidazole, or ingredients present in the FMT * Women who are breastfeeding * Women who are pregnant * Participants with fever \> 100.4F/38C or other signs of active illness * Active treatment with biologics (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab) * Active treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), steroids or any investigational drugs * Crohn's disease like pouch inflammation * Active enteric infection * Isolated cuffitis * Clinically significant strictures of the pouch inlet or outlet * Participation in a clinical trial in the preceding 30 days * Any condition that the physician investigators deems unsafe, including other conditions or medications that the investigator determines will put the participant at greater risk from FMT
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple topical treatment stop a common Post-Surgery complication in ulcerative colitis?
- Sound waves vs. scope: a gentler way to spot pouch inflammation?
- Can a stool transplant calm an inflamed pouch?
- Can a common antibiotic stop pouchitis from coming back?
- New combo tackles stubborn gut inflammation after colitis surgery
- Stem cell shot for pouchitis fails to launch