Phase
Condition
Hepatic Fibrosis
Liver Disease
Scar Tissue
Treatment
Intestinal Microbiota Transplant (IMT) Capsules
Placebo Capsules
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 havingfailed such treatments
Exclusion
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 microscopiccolitis, 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 perinvestigator judgement
Study Design
Study Description
Connect with a study center
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia 23249
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesActive - Recruiting

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