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NCT04373473 · ClinicalTrials.gov registry record · Phase 2
Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis
A Phase 2 study of Adults With Ulcerative Colitis, sponsored by The University of Texas Health Science Center, Houston.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04373473 is a Phase 2 study of Adults With Ulcerative Colitis that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 58 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04373473, a Phase 2 study of Adults With Ulcerative Colitis, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential associations with clinical outcomes in context of active FMT or placebo administration.
Conditions Studied
Interventions
- DRUG PRIM-DJ2727
- DRUG Placebos
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04373473
The ClinicalTrials.gov registry entry for NCT04373473 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 58 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 Adults With Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which PRIM-DJ2727 is the first listed.
NCT04373473 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04373473 about?
NCT04373473 is a clinical study titled "Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis". The purpose of the study is to evaluate the efficacy and safety of lyophilized PRIM-DJ2727 capsules given orally in subjects with ulcerative colitis at remission stage. This study will also include longitudinal analyses of recipient's gut microbiota taxonomy and metagenomics to determine potential a...
What is the current status of trial NCT04373473?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2020-09-14. Estimated completion is 2027-12-31.
What conditions does trial NCT04373473 study?
This clinical trial studies the following conditions: Adults With Ulcerative Colitis.
What interventions are being tested in trial NCT04373473?
The interventions under investigation include: PRIM-DJ2727 (DRUG), Placebos (DRUG).
Who is sponsoring clinical trial NCT04373473?
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 NCT04373473 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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