Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease (IMPACT)

Intestinal Microbiota Transplant in Alcohol-Associated Chronic Liver Disease and Cirrhosis: A Randomized, Double-Blind, Placebo-Controlled Clinical 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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis; Alcohol Use Disorder; Liver Disease; Alcohol-Related
• Intervention / Treatment: Drug: Intestinal Microbiota Transplant (IMT) Capsules; Drug: Placebo Capsules

Detailed Description

These intestinal microbiota transplant (IMT) capsules are an investigational drug, which means it has not been approved by the U. S. Food and Drug Administration (FDA). In this study, drug name will be compared to placebo (a look-alike inactive substance, a "sugar pill").

Participants will be randomly assigned (like the flip of a coin) to receive either IMT capsules or placebo capsules. Participants have an equal chance of being assigned to any one of the groups.

In this study, participants will be asked to do the following things:

1. Visit VCU medical center up to 8 times for study visits
2. Take either IMT capsule or the placebo, depending upon which group they are assigned to; these capsules will be given twice on enrollment and after one month
3. Have blood drawn, urine and stool collected at each visit
4. Have testing done to determine the speed of brain function
5. Keep a diary at home
6. Take surveys and answer questions about general health, alcohol craving and consumption and how they are feeling.
7. Give permission for the researchers to collect information about liver disease, alcohol and mental health from medical records.

Participation in this study will last up to 7 months.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jasmohan S Bajaj, MD; Phone Number: 804 675 5802; Email: jasmohan.bajaj@vcuhealth.org
• Study Contact Backup: Name: Amy Bartels, BSN, RN; Phone Number: 804-828-3849; Email: Amy.Bartels1@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23249
      • Recruiting
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 obstruction
• Ongoing absorbable antibiotic use
• Severe anaphylactic food allergy
• allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
• Adverse event attributable to prior IMT
• ASA Class IV or V
• Pregnant or nursing patients
• acute illness or fever on the day of planned FMT
• Immunosuppression
• Other conditions which make patients are poor candidate for this study per investigator judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intestinal Microbiota Transplant capsules; Capsules will be provided twice during the trial	Drug: Intestinal Microbiota Transplant (IMT) Capsules; Capsules containing freeze-dried intestinal microbiota from healthy human donors
Placebo Comparator: Placebo capsules; Capsules will be provided twice during the trial	Drug: Placebo Capsules; Capsules containing an inactive substance ("sugar pill")

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of abstinent days	Number of drinks per day will be measured through self report	Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Phosphatidyl Ethanol (PEth) level change	Change to <70	Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)
Change in WHO drinking levels by 1 or greater at month 3	WHO grade by self report	Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in markers of alcohol in urine	Urine samples will be analyzed for levels of Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS)	Baseline to 3 months after treatment
Change in markers of alcohol in blood	Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)	Baseline to 3 months after treatment
Change in percentage of heavy drinking days	Self reported drinking behavior will be used to calculate percentage of heavy drinking days	Baseline to 3 months after treatment
Change in alcohol craving	The Alcohol Craving Questionnaire is a 12-item instrument	Baseline to 3 months after treatment
Change in life problems	The Short Index of Problems is a 15-item instrument which measures medical, psychological, social, occupational, and legal problems.	Baseline to 3 months after treatment
Number of hospitalizations	All hospitalizations and liver-related hospitalizations will be tracked	6 months
Number of serious adverse events	All serious adverse events and intervention related adverse events will be tracked	6 months
Change in microbial composition	Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples.	Baseline to 3 months after treatment
Change in liver function	The Model for end-stage liver disease (MELD) score will be used to asses changes in liver function.	Baseline to 3 months after treatment
Change in Psychometric hepatic encephalopathy score (PHES)	Brain function will be assessed using the PHES	Baseline to 3 months after treatment
Change in EncephalApp Stroop Test	Brain function will be assessed using the EncephalApp Stroop Test	Baseline to 3 months after treatment
Change in health related quality of live (HRQOL)	HRQOL will be assessed using the Sickness Impact Profile	Baseline to 3 months after treatment

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Jasmohan S Bajaj, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Liver Disease; Cirrhosis; Alcohol Use Disorder; Intestinal Microbiota Transplant
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Digestive System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Pathological Conditions, Signs and Symptoms; Alcoholism; Fibrosis; Liver Diseases; Pharmaceutical Preparations; Therapeutics; Dosage Forms; Biological Therapy; Fecal Microbiota Transplantation; Capsules
• Other Study ID Numbers: HM20025442; R01AA029398 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data via NIAAA DA website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No