NCT05829109 Fecal Microbiota Transplant for Patients With Chronic Pouchitis
| NCT ID | NCT05829109 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Maia Kayal |
| Condition | Chronic Pouchitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-10-03 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2024-10-03 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Maia Kayal, MD, MS
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05829109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pouchitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05829109 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05829109 currently recruiting?
Yes, NCT05829109 is actively recruiting participants. Contact the research team at Maia.Kayal@mountsinai.org for enrollment information.
Where is the NCT05829109 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05829109 clinical trial?
NCT05829109 is sponsored by Maia Kayal. The principal investigator is Maia Kayal, MD, MS at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 16 participants.