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NCT05829109 · ClinicalTrials.gov registry record · Early Phase 1
Fecal Microbiota Transplant for Patients With Chronic Pouchitis
A Early Phase 1 study of Pouchitis and Chronic Pouchitis, sponsored by Maia Kayal.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05829109: Recruiting Early Phase 1 study of Pouchitis and Chronic Pouchitis, sponsored by Maia Kayal.
NCT05829109 is a Early Phase 1 study of Pouchitis and Chronic Pouchitis that is actively recruiting participants, run by Maia Kayal. The registered enrollment target is 16 participants, below the 24-participant average among 5 other Pouchitis trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05829109, a Early Phase 1 study of Pouchitis and Chronic Pouchitis, is actively recruiting participants, sponsored by Maia Kayal.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The number of patients with FMT related adverse events through week 8 classified according to the Medical Dictionary for Regulatory Activities (MedDRA) and categorized according to the NIH Criteria for Adverse Events.
Conditions Studied
Interventions
- DRUG Fecal Microbiota Transplant (FMT)
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What NCT05829109 shows while recruiting
NCT05829109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 24-participant average among 5 other Pouchitis trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Pouchitis appearing as the primary indexed condition, and to 1 intervention - of which Fecal Microbiota Transplant (FMT) is the first listed.
NCT05829109 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05829109 about?
NCT05829109 is a clinical study titled "Fecal Microbiota Transplant for Patients With Chronic Pouchitis". The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.
What is the current status of trial NCT05829109?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2024-09-01. Estimated completion is 2026-12.
What conditions does trial NCT05829109 study?
This clinical trial studies the following conditions: Pouchitis, Chronic Pouchitis.
What interventions are being tested in trial NCT05829109?
The interventions under investigation include: Fecal Microbiota Transplant (FMT) (DRUG).
Who is sponsoring clinical trial NCT05829109?
This trial is sponsored by Maia Kayal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05829109 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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