Fecal microbiota transplant for chronic pouchitis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the safety and efficacy of fecal microbiota transplant (FMT) in patients suffering from chronic pouchitis, a condition that can arise after surgery for ulcerative colitis. The study aims to use stool from healthy pouch donors to restore a healthy microbiome in recipients, addressing the limitations of previous studies that used stool from colon donors. Participants will be monitored for improvements in symptoms and overall health following the transplant. The study is designed for patients who have not responded to conventional antibiotic therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Maia Kayal, MD, MS — Icahn School of Medicine at Mount Sinai
• Study coordinator: Maia Kayal, MD, MS
• Email: Maia.Kayal@mountsinai.org
• Phone: 212-241-0150

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Etrasimod to Help Prevent Pouchitis After Pouch Surgery

  This study tests whether etrasimod, taken daily, can help prevent pouchitis in adults who had total proctocolectomy with ileal-pouch anal anastomosis for ulcerative colitis and are currently in remission.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07486921

• Guselkumab and diet for chronic or relapsing pouchitis

  This project will test whether the drug guselkumab plus a high-fruit, low ultra-processed-food diet helps adults with chronic or relapsing pouchitis.

  Recruiting Phase 4 Universitaire Ziekenhuizen KU Leuven · Leuven, Vlaams-Brabant · NCT06916390

• Evaluating the safety and effectiveness of vedolizumab in children and teenagers with chronic pouchitis

  This study is testing if a medication called vedolizumab can help children and teenagers with chronic pouchitis feel better and stay healthy after bowel surgery.

  Recruiting at 14 sites Phase 3 Takeda · Leuven, Vlaams-Brabant and 13 other locations · NCT06443502

• Using rifaximin to prevent recurrent pouchitis after surgery

  This study is testing if taking rifaximin daily for a year can help prevent pouchitis from coming back in people who have had surgery for ulcerative colitis.

  Recruiting at 2 sites Phase 4 University of North Carolina, Chapel Hill · New York, New York and 1 other locations · NCT06312683

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.