Actively Recruiting
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
Led by Maia Kayal · Updated on 2025-07-15
16
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
CONDITIONS
Official Title
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older with ulcerative colitis who have undergone total proctocolectomy with ileal pouch-anal anastomosis
- Chronic antibiotic dependent pouchitis requiring continuous antibiotic therapy (>4 weeks) with at least 2 attempts to stop antibiotics causing pouchitis episodes in 24 months
- Active pouchitis with modified Pouchitis Disease Activity Index (mPDAI) 25 5 and history of 254 antibiotic therapies in last 12 months
- Chronic antibiotic refractory pouchitis with active pouchitis (mPDAI 25 5) and no response to antibiotics
- Crohn's disease-like pouch inflammation on biologic or small molecule therapy with persistent symptoms (mPDAI clinical sub-score 262), including pre-pouch ileal inflammation, strictures, and/or fistulae, with active therapy
You will not qualify if you...
- Allergy to vancomycin, metronidazole, or ingredients in the fecal microbiota transplant
- Women who are breastfeeding or pregnant
- Participants with fever above 100.4F/38C or signs of active illness
- Active treatment with biologic drugs (e.g., infliximab, adalimumab, golimumab, vedolizumab, ustekinumab)
- Active treatment with immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), steroids, or investigational drugs
- Crohn's disease-like pouch inflammation (unless meeting inclusion criteria)
- Active enteric infection
- Isolated cuffitis
- Significant strictures of the pouch inlet or outlet
- Participation in another clinical trial within 30 days
- Any condition deemed unsafe by the investigator, including other conditions or medications increasing risk from FMT
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Maia Kayal, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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