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NCT05786404 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis
A Phase 1 study of Active Ulcerative Colitis (UC), sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05786404: Recruiting Phase 1 study of Active Ulcerative Colitis (UC), sponsored by The University of Texas Health Science Center, Houston.
NCT05786404 is a Phase 1 study of Active Ulcerative Colitis (UC) that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05786404, a Phase 1 study of Active Ulcerative Colitis (UC), is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and proportion of antibody-coated microbiota from baseline to after completion of FMT.
Primary Outcome
This is a 3 item questionnaire and each is measured from 0-3, for a maximum score of 9 a higher number indicating worse outcome
Conditions Studied
Interventions
- DRUG PRIM-DJ2727 - FROZEN
- DRUG PRIM-DJ2727 - CAPSULES
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-12-15 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 1 |
What NCT05786404 shows while recruiting
NCT05786404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Active Ulcerative Colitis (UC) appearing as the primary indexed condition, and to 2 interventions - of which PRIM-DJ2727 - FROZEN is the first listed.
NCT05786404 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05786404 about?
NCT05786404 is a clinical study titled "Study to Evaluate the Fecal Microbiota Transplantation (FMT) in the Treatment of Ulcerative Colitis". The study is to evaluate the safety, feasibility, and preliminary efficacy of frozen FMT delivery via retention enema compared to lyophilized powder given in oral capsules as induction FMT in subjects with active UC. This study will also determine changes in microbiome (diversity and genera) and pro...
What is the current status of trial NCT05786404?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-12-15. Estimated completion is 2027-12-15.
What conditions does trial NCT05786404 study?
This clinical trial studies the following conditions: Active Ulcerative Colitis (UC).
What interventions are being tested in trial NCT05786404?
The interventions under investigation include: PRIM-DJ2727 - FROZEN (DRUG), PRIM-DJ2727 - CAPSULES (DRUG).
Who is sponsoring clinical trial NCT05786404?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05786404 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05786404's enrollment target sits among peer trials
20 1630th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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