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Recruiting NCT05548452

Intestinal Microbiota Transplant in Alcohol-Associated Liver Disease

Phase I / Phase II Interventional Liver Disease; Alcohol-Related Cirrhosis Alcohol Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intestinal Microbiota Transplant (IMT) Capsules, Placebo Capsules.
Who it may be relevant to
Registry conditions: Liver Disease; Alcohol-Related, Cirrhosis, Alcohol Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

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)]
  • 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)]
  • Phosphatidyl Ethanol (PEth) level change [Time frame: Baseline to 3 months after treatment (analysis of all 3 primary outcomes via Win Ratio)]
Secondary outcome measures (12)
  • Change in markers of alcohol in urine [Time frame: Baseline to 3 months after treatment]
  • Change in markers of alcohol in blood [Time frame: Baseline to 3 months after treatment]
  • Change in percentage of heavy drinking days [Time frame: Baseline to 3 months after treatment]
  • Change in alcohol craving [Time frame: Baseline to 3 months after treatment]
  • Change in life problems [Time frame: Baseline to 3 months after treatment]
  • Number of hospitalizations [Time frame: 6 months]
  • Number of serious adverse events [Time frame: 6 months]
  • Change in microbial composition [Time frame: Baseline to 3 months after treatment]
  • Change in liver function [Time frame: Baseline to 3 months after treatment]
  • Change in Psychometric hepatic encephalopathy score (PHES) [Time frame: Baseline to 3 months after treatment]
  • Change in EncephalApp Stroop Test [Time frame: Baseline to 3 months after treatment]
  • Change in health related quality of live (HRQOL) [Time frame: Baseline to 3 months after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Hunter Holmes McGuire VA Medical Center — Richmond
  • Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT05548452 · HM20025442 · R01AA029398

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗