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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05786404
The ClinicalTrials.gov registry entry for NCT05786404 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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