An Early Phase 1 interventional study of Fecal Microbiota Transplant (FMT) in Chronic Pouchitis and Pouchitis, sponsored by Maia Kayal. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Maia Kayal · Early Phase 1, Interventional, and Treatment
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis. FMT has been successfully used in the treatment of recurrent Clostridiodes difficile infection and has shown benefit in the treatment of ulcerative colitis in clinical trials. The success of FMT in these patients is because of the reconstitution of the recipient's unhealthy gut bacteria with the donor's healthy gut bacteria.
Surgery to remove the colon is required in a subset of patients with ulcerative colitis that does not respond to medical therapy. In these patients, an internal pouch is created from small intestine to function as a stool reservoir and avoid an ostomy after the colon is removed. Inflammation of the pouch, pouchitis, is common after surgery and can manifest as diarrhea, pelvic pain, urgency and blood in the stool. Chronic pouchitis occurs in up to 20% of patients and there is no approved treatment. A number of studies have evaluated FMT in patients with chronic pouchitis, but have proven unsuccessful. This is likely because these studies have used stool from patients with a colon and transplanted it into patients with a pouch. This is problematic because the gut bacteria of the colon and pouch are not similar, and putting healthy stool from a colon may not reconstitute a healthy pouch microbiome. The specific purpose of this project is to transplant stool from patients with a healthy pouch to patients with an inflamed pouch.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's planned enrollment of 16 is below the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Maia Kayal is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Patients with UC who underwent TPC with IPAA and meet one of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm of 16-18 subjects, all of whom will receive the interventional FMT.
Drug: Fecal Microbiota Transplant (FMT)
The intervention consists of the following steps: * Step 1: Vancomycin 125 mg orally every 6 hours and metronidazole 250 mg orally every 6 hours for 5 days. * Step 2: Bowel preparation with 10 ounces of magnesium citrate. * Step 3: Two FMT doses will be administered via enema one week apart using stool from donors with a durably healthy pouch.
Number of patients with FMT related adverse events
The number of patients with FMT related adverse events through week 8 classified according to the Medical Dictionary for Regulatory Activities (MedDRA) and categorized according to the NIH Criteria for Adverse Events.
Time frame: 8 weeks
Number of patients in clinical remission
The number of patients in clinical remission assessed via patient interview and defined as mPDAI clinical subscore ≤4 points and no need for antibiotic therapy at week 8.
Time frame: 8 weeks
Number of patients with endoscopic response
The number of patients with endoscopic response assessed via pouchoscopy and defined as a decrease from baseline in mPDAI endoscopic subscore \> 2 points at week 8.
Time frame: 8 weeks
Change in recipient fecal microbial diversity via metagenomics analysis
The change in recipient fecal microbial diversity after FMT relative to baseline assessed via stool collection and using metagenomics analysis.
Time frame: Baseline and up to 8 weeks
Change in recipient fecal microbial diversity via strain strain isolation
The change in recipient fecal microbial diversity after FMT relative to baseline assessed via strain isolation - to isolate and sequence the gut microbial strains from each donor
Time frame: Baseline and up to 8 weeks
Change in recipient microbe tracking
The change in recipient fecal microbial diversity after FMT relative to baseline assessed by recipient microbe tracking.
Time frame: Baseline and up to 8 weeks
Change in B cells
The change in the mucosal immune profile before and after FMT as measured by B cells
Time frame: Baseline and 8 weeks
Change in myeloid cells
The change in the mucosal immune profile before and after FMT as measured by myeloid cells
Time frame: Baseline and 8 weeks
Change in T cells
The change in the mucosal immune profile before and after FMT as measured by T cells
Time frame: Baseline and 8 weeks
Change in NK cell subsets
The change in the mucosal immune profile before and after FMT as measured by NK cell subsets
Time frame: Baseline and 8 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals should be directed to Maia.Kayal@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (tbd).
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jun 2027, 32 months after the start.
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Studies of the drug tested here: Fecal microbiota
Maia Kayal