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Microbiota Transplant

Bacteria Capsules for Alcoholic Liver Disease (IMPACT Trial)

Phase 1 & 2
Recruiting
Led By Jasmohan S Bajaj, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months

Summary

This trial will test if bacteria capsules can help people with alcohol cravings and drinking.

Who is the study for?
This trial is for adults over 18 with advanced liver disease due to alcohol use, who continue to drink despite previous attempts at treatment. They must be able to consent and not have withdrawal symptoms, significant drug use, uncontrolled mood disorders, certain allergies, a high MELD score (>17), or other severe health issues.
What is being tested?
The study tests if capsules containing bacteria from healthy donors can reduce alcohol craving and consumption in patients with alcoholic liver disease. Participants will either receive the actual microbiota capsules or placebo capsules without active ingredients.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include gastrointestinal discomfort or allergic reactions to capsule ingredients. The safety and tolerability of these microbiota capsules are key aspects being evaluated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ethanol
Secondary study objectives
Change in EncephalApp Stroop Test
Hepatic Encephalopathy
Change in alcohol craving
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intestinal Microbiota Transplant capsulesExperimental Treatment1 Intervention
Capsules will be provided twice during the trial
Group II: Placebo capsulesPlacebo Group1 Intervention
Capsules will be provided twice during the trial

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
716 Previous Clinical Trials
22,888,418 Total Patients Enrolled
10 Trials studying Alcoholism
14,553 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,690 Total Patients Enrolled
456 Trials studying Alcoholism
823,706 Patients Enrolled for Alcoholism
Jasmohan S Bajaj, MDPrincipal InvestigatorVirginia Commonwealth University
7 Previous Clinical Trials
607 Total Patients Enrolled
1 Trials studying Alcoholism
20 Patients Enrolled for Alcoholism

Media Library

Intestinal Microbiota Transplant (IMT) Capsules (Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT05548452 — Phase 1 & 2
Alcoholism Research Study Groups: Intestinal Microbiota Transplant capsules, Placebo capsules
Alcoholism Clinical Trial 2023: Intestinal Microbiota Transplant (IMT) Capsules Highlights & Side Effects. Trial Name: NCT05548452 — Phase 1 & 2
Intestinal Microbiota Transplant (IMT) Capsules (Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548452 — Phase 1 & 2
~39 spots leftby Nov 2026
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