Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Advanced liver disease
Able to give written, informed consent
Alcohol as a cause of advanced liver disease
Continued sustained drinking
Disqualifiers
Lack of sustained drinking
Recent or current alcoholic hepatitis
Alcohol withdrawal symptoms
Clinically significant use of illicit drugs
Trial design
Design model
Parallel
Treatments tested in this trial
Intestinal Microbiota Transplant (IMT) Capsules
DrugCapsules containing freeze-dried intestinal microbiota from healthy human donors
Placebo Capsules
DrugCapsules containing an inactive substance ("sugar pill")
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Intestinal Microbiota Transplant capsulesExperimental treatment 1 intervention
Group B: Placebo capsulesPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of abstinent days
Number of drinks per day will be measured through self report
Time frame
Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)2
Change in WHO drinking levels by 1 or greater at month 3
WHO grade by self report
Time frame
Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)3
Phosphatidyl Ethanol (PEth) level change
Change to \<70
Time frame
Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)Secondary outcomes
1
Change in markers of alcohol in urine
Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS)
Time frame
Baseline to 3 months after treatment2
Change in markers of alcohol in blood
Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)
Time frame
Baseline to 3 months after treatment3
Change in percentage of heavy drinking days
Self reported drinking behavior will be used to calculate percentage of heavy drinking days
Time frame
Baseline to 3 months after treatment4
Change in alcohol craving
The Alcohol Craving Questionnaire is a 12-item instrument
Time frame
Baseline to 3 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov