Actively Recruiting
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
Led by Virginia Commonwealth University · Updated on 2026-05-06
80
Participants Needed
2
Research Sites
214 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Diagnosed with advanced liver disease
- Able to provide written informed consent
- Alcohol is the cause of advanced liver disease
- Continued sustained drinking
- Previously declined or failed traditional alcohol use disorder therapy services
You will not qualify if you...
- Lack of sustained drinking
- Recent or current alcoholic hepatitis
- Alcohol withdrawal symptoms
- Clinically significant use of illicit drugs
- Uncontrolled mood disorders or primary psychotic conditions
- MELD score greater than 17
- Unclear diagnosis of chronic liver disease
- Current hepatic encephalopathy on lactulose and/or rifaximin
- White blood cell count less than 1000
- Non-elective hospitalization within the last month
- On dialysis
- Known untreated luminal gastrointestinal cancers
- Chronic intrinsic gastrointestinal diseases such as ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis, or celiac disease
- Dysphagia within 2 weeks
- History of aspiration, gastroparesis, or intestinal obstruction
- Ongoing use of absorbable antibiotics
- Severe anaphylactic food allergy
- Allergy to ingredients generally recognized as safe in the study capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
- Adverse event related to prior intestinal microbiota transplant
- ASA Class IV or V
- Pregnant or nursing
- Acute illness or fever on the day of planned fecal microbiota transplant
- Immunosuppression
- Other conditions making patient a poor candidate per investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Actively Recruiting
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
J
Jasmohan S Bajaj, MD
CONTACT
A
Amy Bartels, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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