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NCT05006430 · ClinicalTrials.gov registry record · Phase 1
Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis
A Phase 1 study of Alcoholic Hepatitis, sponsored by Prasun Kumar Jalal.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05006430: Recruiting Phase 1 study of Alcoholic Hepatitis, sponsored by Prasun Kumar Jalal.
NCT05006430 is a Phase 1 study of Alcoholic Hepatitis that is actively recruiting participants, run by Prasun Kumar Jalal. The registered enrollment target is 50 participants, below the 291-participant average among 5 other Alcoholic Hepatitis trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05006430, a Phase 1 study of Alcoholic Hepatitis, is actively recruiting participants, sponsored by Prasun Kumar Jalal.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension from well screened health donors. The study aims to enroll 50 patients with SAH who will be randomly assigned in 1:1 where 25 patients will be assigned to receive orally administered lyophilized PRIM-DJ2727 and Standard of Care (SOC) and the other 25 patients will be assigned to receive placebo and SOC for 4 weeks.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Fecal Microbiota Transplantation
Study Locations (1)
Texas
- Baylor St. Luke Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-01-21 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
What NCT05006430 shows while recruiting
NCT05006430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 291-participant average among 5 other Alcoholic Hepatitis trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Alcoholic Hepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05006430 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05006430 about?
NCT05006430 is a clinical study titled "Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis". This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following ...
What is the current status of trial NCT05006430?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2023-01-21. Estimated completion is 2025-06-30.
What conditions does trial NCT05006430 study?
This clinical trial studies the following conditions: Alcoholic Hepatitis.
What interventions are being tested in trial NCT05006430?
The interventions under investigation include: Placebo (OTHER), Fecal Microbiota Transplantation (BIOLOGICAL).
Who is sponsoring clinical trial NCT05006430?
This trial is sponsored by Prasun Kumar Jalal, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05006430 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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