Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

NCT02255617 | Completed Phase 1 DMC

• 1 other identifier: 47057
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Portion of participants with normailzation of ICT or Stroop Test during the study

  8 weeks

Secondary Outcomes (7)

• Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8

  8 weeks

• Changes in serum ammonia level pre and post FMT

  8 weeks

• Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT

  8 weeks

• Changes in Intestinal Microbiota pre and post FMT

  8 weeks

• Serious Adverse Events

  8 weeks

Study Arms (1)

Fecal Microbiota Transplant

EXPERIMENTAL

Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema

Biological: Fecal Microbiota Transplant

Interventions

Fecal Microbiota Transplant BIOLOGICAL

Fecal transplant processed from routinely screened universal donors

Fecal Microbiota Transplant

Eligibility Criteria

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

You may qualify if:

• adult (age \> 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
• abnormal inhibitory control test, defined as greater than 5 lures.
• an infectious etiology which may cause HE has been ruled out

You may not qualify if:

• those with tense ascites
• those who do not provide assent
• those who are judged to have a life expectancy of less than 3 months,
• those who had TIPS within 3 months,
• those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
• pregnancy
• those with intestinal obstruction
• those with alcoholic hepatitis
• those with active alcohol or substance abuse
• those without stable social support
• those who have a concurrent infection, such as SBP, pneumonia or UTI
• those with creatinine clearance less than 50% compared to baseline
• those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2014
• First Posted: October 2, 2014
• Study Start: July 23, 2014
• Primary Completion: July 25, 2019
• Study Completion: September 23, 2019
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

CA (1)