RecruitingEarly Phase 1NCT05829109

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Safety and Efficacy of Healthy to Inflamed Pouch Fecal Microbiota Transplantation


Sponsor

Maia Kayal

Enrollment

16 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether fecal microbiota transplantation (FMT) — transferring stool from a healthy donor into a patient's gut — can effectively treat chronic pouchitis, a recurring inflammatory condition that affects people who have had their colon removed for ulcerative colitis and have had a pouch created from the small intestine. Pouchitis causes diarrhea, urgency, pain, and significant reduction in quality of life. It is often difficult to control with antibiotics and represents a major ongoing complication in this patient population. Adults aged 18 and older with ulcerative colitis who have undergone total proctocolectomy with ileal pouch-anal anastomosis (IPAA) and have chronic antibiotic-dependent pouchitis, chronic antibiotic-refractory pouchitis, or Crohn's disease-like pouch inflammation with persistent symptoms despite medical therapy are eligible. Patients currently on biologics (for antibiotic-dependent or antibiotic-refractory types), active enteric infections, who are pregnant or breastfeeding, or have allergies to study medications are not eligible. Participants will receive FMT and be assessed for remission of pouchitis symptoms and endoscopic findings. This research is important because pouchitis significantly undermines the benefit of having had surgery and can even threaten the pouch itself. FMT, which has revolutionized treatment for recurrent Clostridioides difficile infection, represents a promising and biologically rational approach to rebalancing the altered microbiome in these patients and potentially achieving sustained remission.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFecal 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.


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT05829109


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