Oral Fecal Transplant in Cirrhosis

• Status: Completed
• Trial end date: 2018-11-12
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis and hepatic encephalopathy

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborators: Hunter Holmes McGuire VA Medical Center; Medical College of Wisconsin; National Institutes of Health (NIH); OpenBiome

Criteria

Inclusion Criteria:

• 21-75 years of age

• Cirrhosis diagnosed by either of the following in a patient with chronic liver disease (a) Liver Biopsy (b) Radiologic evidence of varices, cirrhosis or portal hypertension (c) Laboratory evidence of platelet count <100,000 or AST/ALT ratio>1 (d) Endoscopic evidence of varices or portal gastropathy

• At least two HE episodes, one within the last year but not within the last month (patient can be on lactulose and rifaximin)

• Able to give written, informed consent (mini-mental status exam>25 at the time of consenting)

Exclusion Criteria:

Disease-related: (1) MELD score>17 (2) WBC count<1000 (3) TIPS, non-elective hospitalization or HE within last month (4) on dialysis (5) known untreated, in-situ luminal GI cancers (6) chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease or microscopic colitis, eosinophilic gastroenteritis and celiac disease) Endoscopy-related: (1) Platelet count<50,000 (2) adverse reactions to sedation (3) lack of driver or other contra-indications Safety-related: (1) Dysphagia (2) History of aspiration, gastroparesis, intestinal obstruction (3) Ongoing absorbable antibiotic use (4) Severe anaphylactic food allergy (5) allergy to ingredients Generally Recognized As Safe in the G3 capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil) (6) Adverse event attributable to prior FMT (7) ASA Class IV or V (8) Pregnant or nursing patients (9) acute illness or fever on the day of planned FMT