Fecal microbiota transplant for chronic pouchitis treatment
Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation
This study is testing whether a fecal microbiota transplant from healthy donors can help people with chronic pouchitis feel better when other treatments haven't worked.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, methotrexate |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05829109 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a history of chronic antibiotic-dependent pouchitis or active pouchitis requiring multiple antibiotic treatments.
Not a fit: Patients with active infections, those on certain immunosuppressive therapies, or those with specific allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with chronic pouchitis who currently have no approved therapies.
How similar studies have performed: Previous studies using fecal microbiota transplant for chronic pouchitis have not been successful, making this approach novel as it focuses on using stool from healthy pouch donors.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.