Fecal Transplant in Recurrent Hepatic Encephalopathy

NCT02636647 | Completed Phase 1 DMC

• 1 other identifier: BAJAJ0021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label safety, tolerability study with exploratory endpoints and pathophysiological evaluation of the FMT Two groups of outpatients with cirrhosis will be randomized using random sequence generator into no-treatment and FMT groups.

Conditions

Hepatic Encephalopathy; Cirrhosis

Keywords

hepatic encephalopathy; fecal transplant; cirrhosis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Defined by the rate of development of FMT-related SAE and withdrawal from the study in cirrhotic subjects

  5 months

Secondary Outcomes (2)

• Microbiota composition and function

  15 days

• Cognitive functioning

  15 days

Study Arms (2)

FMT

ACTIVE COMPARATOR

Fecal transplant via enema once

Biological: Fecal transplant

No treatment

NO INTERVENTION

No transplant performed

Interventions

Fecal transplant BIOLOGICAL

FMT

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis diagnosed by either of the following in a patient with chronic liver disease
• Liver Biopsy
• Radiologic evidence of varices, cirrhosis or portal hypertension
• Laboratory evidence of platelet count \<100,000 or AST/ALT ratio\>1
• Endoscopic evidence of varices or portal gastropathy
• At least two episodes of hepatic encephalopathy, one within the last year but not within the last month (patient can be on lactulose and rifaximin)
• Age between 21 and 75
• Able to give written, informed consent (demonstrated by mini-mental status exam\>25 at the time of consenting)

You may not qualify if:

• MELD score \>17
• WBC count \<1000 cells/mm3
• Platelet count\<50,000/mm3
• On the liver transplant list
• TIPS in place
• No HE episode within a month prior to the study
• Patients allergic to ciprofloxacin, penicillins or metronidazole
• Currently on absorbable antibiotics
• Infection at the time of the FMT (diagnosed by blood culture positivity, urinalysis, paracentesis as needed)
• Hospitalization for any non-elective cause within the last 3 months
• Patients who are aged \>75 years
• Patients who are pregnant or nursing (will be checked using a urine pregnancy test)
• Patients who are incarcerated
• Patients who are incapable of giving their own informed consent
• Patients who are immuno-compromised due to the following reasons:

Sponsors & Collaborators

• Jasmohan Bajaj: lead
• OpenBiome: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Hepatic Encephalopathy; Fibrosis

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 22, 2015
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)