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NCT05548452 · ClinicalTrials.gov registry record · Phase 1

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

A Phase 1 study of Alcohol Use Disorder and Cirrhosis, sponsored by Virginia Commonwealth University.

Recruiting
Registry status
Phase 1
Development phase
80
Enrollment target
2
Study locations

NCT05548452 is a Phase 1 study of Alcohol Use Disorder and Cirrhosis that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 80 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05548452, a Phase 1 study of Alcohol Use Disorder and Cirrhosis, is actively recruiting participants, sponsored by Virginia Commonwealth University.

RECRUITING
Registry status
Phase 1
Development phase
80 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

Interventions

  • DRUG Intestinal Microbiota Transplant (IMT) Capsules
  • DRUG Placebo Capsules

Study Locations (2)

Virginia

  • Hunter Holmes McGuire VA Medical Center - Richmond
  • Virginia Commonwealth University - Richmond

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2022-11-21
Est. Completion 2026-12-30
Phase Phase 1

Sponsor

Virginia Commonwealth University

558 total trials

What the Registry Record Tells You About NCT05548452

The ClinicalTrials.gov registry entry for NCT05548452 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (76% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Intestinal Microbiota Transplant (IMT) Capsules is the first listed.

NCT05548452 reports 2 study locations spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT05548452 about?

NCT05548452 is a clinical study titled "Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease". The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.

What is the current status of trial NCT05548452?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2022-11-21. Estimated completion is 2026-12-30.

What conditions does trial NCT05548452 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Cirrhosis, Liver Disease; Alcohol-Related.

What interventions are being tested in trial NCT05548452?

The interventions under investigation include: Intestinal Microbiota Transplant (IMT) Capsules (DRUG), Placebo Capsules (DRUG).

Who is sponsoring clinical trial NCT05548452?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05548452 being conducted?

This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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