Chronic PouchitisEarly Phase 1NCT05829109
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
A Early Phase 1 study testing Fecal Microbiota Transplant (FMT) in people with Chronic Pouchitis and Pouchitis, run by Maia Kayal at 1 site in United States.
Trial summary
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pouchitis, Pouchitis
- What is being tested?
- Fecal Microbiota Transplant (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to Sep 2027
- Phase
- Early Phase 1
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
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
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Maia Kayal, MD, MS, 212-241-0150, Maia.Kayal@mountsinai.org
Maia Kayal
About this study
Official title: Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
Read the detailed description
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.
- Conditions
- Chronic Pouchitis, Pouchitis
- Being tested
- Fecal Microbiota Transplant (FMT)
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplant (FMT) | Experimental | Single arm of 16-18 subjects, all of whom will receive the interventional FMT. Receives: Drug: Fecal Microbiota Transplant (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline and 8 weeks
Change in myeloid cells
The change in the mucosal immune profile before and after FMT as measured by myeloid cells
Measured: Baseline and 8 weeks
Change in T cells
The change in the mucosal immune profile before and after FMT as measured by T cells
Measured: 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
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start3 Oct 2024
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PouchitisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a pilot study of 16-18 patients who will each receive FMT.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maia Kayal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maia Kayal, Icahn School of Medicine at Mount Sinai
- Investigators
- Maia Kayal, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829109
- Sponsor's protocol ID
- STUDY-22-01753
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).