NCT05548452 · Virginia Commonwealth University
Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
(IMPACT)
What this study 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.
View original scientific description
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
Capsules containing freeze-dried intestinal microbiota from healthy human donors
DRUG
Placebo Capsules
Capsules containing an inactive substance ("sugar pill")
Primary outcome measures
Number of abstinent days
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Number of drinks per day will be measured through self report
Change in WHO drinking levels by 1 or greater at month 3
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
WHO grade by self report
Phosphatidyl Ethanol (PEth) level change
Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Change to \<70
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- -\>18 years of age
- Advanced liver disease
- Able to give written, informed consent
- Alcohol as a cause of advanced liver disease
- Continued sustained drinking
- Having previously declined a referral to traditional AUD therapy services or having failed such treatments
Exclusion criteria
- 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\>17
- Unclear diagnosis of chronic liver disease
- Current hepatic encephalopathy on lactulose and/or rifaximin
- WBC count\<1000
- Non-elective hospitalization within last month
- on dialysis
- known untreated, in-situ luminal GI cancers
- chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease)
- Dysphagia within 2 weeks
- History of aspiration, gastroparesis, intestinal obstr
Where
- Richmond, Virginia
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations