Intestinal Microbiota Transplant (IMT) Capsules for Alcohol Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Alcohol Use Disorder+7 More
Intestinal Microbiota Transplant (IMT) Capsules - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Alcohol Use Disorder
  • Disease
  • Cirrhosis of the Liver

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Alcohol Use Disorder

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 6 months

6 months
Number of hospitalizations
Number of serious adverse events
Month 3
Change in Alcohol consumption
Change in EncephalApp Stroop Test
Change in Psychometric hepatic encephalopathy score (PHES)
Change in alcohol craving
Change in health related quality of live (HRQOL)
Change in life problems
Change in liver function
Change in markers of alcohol in blood
Change in markers of alcohol in urine
Change in microbial composition
Change in percentage of heavy drinking days

Trial Safety

Safety Progress

1 of 3

Other trials for Alcohol Use Disorder

Trial Design

2 Treatment Groups

Intestinal Microbiota Transplant capsules
1 of 2
Placebo capsules
1 of 2
Experimental Treatment
Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Intestinal Microbiota Transplant (IMT) Capsules · Has Placebo Group · Phase 1 & 2

Intestinal Microbiota Transplant capsules
Drug
Experimental Group · 1 Intervention: Intestinal Microbiota Transplant (IMT) Capsules · Intervention Types: Drug
Placebo capsules
Drug
PlaceboComparator Group · 1 Intervention: Placebo Capsules · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Hunter Holmes McGuire VA Medical Center · Richmond, VA
Photo of Richmond 1Photo of Richmond 2Photo of Richmond 3
2003First Recorded Clinical Trial
0 TrialsResearching Alcohol Use Disorder
60 CompletedClinical Trials

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
692 Previous Clinical Trials
1,168,029 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
609 Previous Clinical Trials
342,305 Total Patients Enrolled
Jasmohan S Bajaj, MDPrincipal InvestigatorVirginia Commonwealth University
7 Previous Clinical Trials
1,043 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are not yet 18 years of age.
You have advanced liver disease.
Alcohol is a cause of advanced liver disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.