Fecal Transplant for Hepatic Encephalopathy | NCT03439982

Studies
Fecal Transplant for Hepatic Encephalopathy

NCT03439982

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

3Actual

Phase

Phase 1Phase 2

Conditions

Hepatic Encephalopathy

Interventions

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2016Actual

Primary Completion Date

Aug 7, 2019Actual

Completion Date

Mar 18, 2021Actual

First Submitted Date

Feb 13, 2018

First Submission Date that Met QC Criteria

Feb 13, 2018

First Posted Date

Feb 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2022

Last Update Posted Date

Jun 10, 2022Actual

Name	Class
Rebiotix Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMT	Experimental	Open label FMT administered at week 0 by colonoscopy and weeks 1-4 by enema	Biological: FMT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FMT	Biological	FMT processed from routinely screened donors	FMT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Portion of participants with normalization of ICT or Stroop Test during the study		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dina Kao, MD	Associate Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital		Edmonton	Alberta		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38109364	Derived	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.

ID	Term
D017093	Liver Failure
D048550	Hepatic Insufficiency
D008107	Liver Diseases
D004066	Digestive System Diseases