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

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cirrhosis; Liver Disease; Alcohol-Related; Alcohol Use Disorder

Treatments: Drug: Placebo Capsules; Drug: Intestinal Microbiota Transplant (IMT) Capsules

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05548452

R01AA029398 (U.S. NIH Grant/Contract)

HM20025442

Details and patient eligibility

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Intestinal Microbiota Transplant capsules

Experimental group

Description:

Capsules will be provided twice during the trial

Treatment:

Drug: Intestinal Microbiota Transplant (IMT) Capsules

Placebo capsules

Placebo Comparator group

Description:

Capsules will be provided twice during the trial

Treatment:

Drug: Placebo Capsules