NCT03439982

Brief Summary

The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

June 10, 2022

Status Verified

July 1, 2021

Enrollment Period

3.3 years

First QC Date

February 13, 2018

Last Update Submit

June 7, 2022

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathy, fecal microbiota transplant

Outcome Measures

Primary Outcomes (1)

  • Portion of participants with normalization 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

  • Change in Intestinal Microbiota pre-and post FMT

    8 weeks

  • Serious Adverse Events

    8 weeks

  • +2 more secondary outcomes

Study Arms (1)

FMT

EXPERIMENTAL

Open label FMT administered at week 0 by colonoscopy and weeks 1-4 by enema

Biological: FMT

Interventions

FMTBIOLOGICAL

FMT processed from routinely screened donors

FMT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
  • Abnormal ICT (\>5 lures) or abnormal Stroop test (\>200 seconds)
  • Baseline Conn score 0 or 1
  • Infectious etiology of HE has been ruled out

You may not qualify if:

  • those with tense ascites
  • those who do not provide assent
  • life expectancy \<3 months
  • TIPS within the past 3 months
  • neurologic disease such as dementia, Parkinson's, structural brain lesions
  • pregnancy
  • intestinal obstruction
  • alcoholic hepatitis
  • active alcohol or substance abuse
  • those without stable social support
  • concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
  • creatinine clearance less that 50% compared to baseline
  • hospital admission for HE within one month of enrollment
  • active hepatocellular carcinoma
  • active GI bleed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Related Publications (1)

  • Pun CK, Huang HC, Chang CC, Hsu SJ, Huang YH, Hou MC, Lee FY. Hepatic encephalopathy: From novel pathogenesis mechanism to emerging treatments. J Chin Med Assoc. 2024 Mar 1;87(3):245-251. doi: 10.1097/JCMA.0000000000001041. Epub 2023 Dec 18.

    PMID: 38109364DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dina Kao, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

April 12, 2016

Primary Completion

August 7, 2019

Study Completion

March 18, 2021

Last Updated

June 10, 2022

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)