Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Alcohol Use Disorder Clinical Trial

— IMPACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548452
• Other study ID #: HM20025442
• Secondary ID: R01AA029398
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 21, 2022
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Virginia Commonwealth University
• Contact: Jasmohan S Bajaj, MD
• Phone: 804 675 5802
• Email: jasmohan.bajaj[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Liver Diseases

Intervention

Drug:
• Intestinal Microbiota Transplant (IMT) Capsules
Capsules containing freeze-dried intestinal microbiota from healthy human donors
• Placebo Capsules
Capsules containing an inactive substance ("sugar pill")

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Alcohol consumption	Number of drinks per day will be measured through self report	Baseline to 3 months after treatment
Secondary	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
Secondary	Change in markers of alcohol in blood	Blood samples will be analyzed for Phosphatidyl Ethanol (PEth)	Baseline to 3 months after treatment
Secondary	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
Secondary	Change in alcohol craving	The Alcohol Craving Questionnaire is a 12-item instrument	Baseline to 3 months after treatment
Secondary	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
Secondary	Number of hospitalizations	All hospitalizations and liver-related hospitalizations will be tracked	6 months
Secondary	Number of serious adverse events	All serious adverse events and intervention related adverse events will be tracked	6 months
Secondary	Change in microbial composition	Percentage of beneficial intestinal bacteria will be assessed by genetic analysis of stool samples.	Baseline to 3 months after treatment
Secondary	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
Secondary	Change in Psychometric hepatic encephalopathy score (PHES)	Brain function will be assessed using the PHES	Baseline to 3 months after treatment
Secondary	Change in EncephalApp Stroop Test	Brain function will be assessed using the EncephalApp Stroop Test	Baseline to 3 months after treatment
Secondary	Change in health related quality of live (HRQOL)	HRQOL will be assessed using the Sickness Impact Profile	Baseline to 3 months after treatment