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Fecal Transplant for Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

FMT

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic encephalopathy, fecal microbiota transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alberta Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT

Arm Description

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

Outcomes

Primary Outcome Measures

Portion of participants with normalization of ICT or Stroop Test during the study

Secondary Outcome Measures

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

Changes in serum ammonia level pre and post FMT

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

29 Questions Total- each question is on a seven point scales, ranging from the worst (1) to the best (7) possible function

Change in Intestinal Microbiota pre-and post FMT

Serious Adverse Events

i) All serious adverse events up to and including week 8. A serious adverse event is any event which results in any of the following: i) Death ii) Colonic perforation iii) Proven infections as defined by the presence of i) spontaneous bacteremia: positive blood cultures in the absence of any other potential source of infection; ii) spontaneous bacterial peritonitis: ascetic fluid PMN equal to or greater than 250/mm3; iii) UTI: urinary leukocyte count greater than 15 cells per HPF and positive urine culture; vi) other infections identified by clinical, radiologic and bacteriologic results. iv) Possible infections as defined by i) fever (temp > 37.80 C), ii) leukocytosis (>15,000 mm3) or increased immature neutrophils in blood (>500 mm3), negative cultures and no other signs of infection.

Change in stool Bile Acids Composition pre and post FMT

Changes in stool short chain free fatty acids pre and post FMT

Full Information

NCT ID

NCT03439982

First Posted

February 13, 2018

Last Updated

June 7, 2022

Sponsor

University of Alberta

Collaborators

Rebiotix Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03439982

Brief Title

Fecal Transplant for Hepatic Encephalopathy

Official Title

A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

April 12, 2016 (Actual)

Primary Completion Date

August 7, 2019 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alberta

Collaborators

Rebiotix Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Encephalopathy

Keywords

Hepatic encephalopathy, fecal microbiota transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FMT

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

FMT

Intervention Description

FMT processed from routinely screened donors

Primary Outcome Measure Information:

Title

Portion of participants with normalization of ICT or Stroop Test during the study

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

8 weeks

Title

Changes in serum ammonia level pre and post FMT

Time Frame

8 weeks

Title

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

Description

29 Questions Total- each question is on a seven point scales, ranging from the worst (1) to the best (7) possible function

Time Frame

8 weeks

Title

Change in Intestinal Microbiota pre-and post FMT

Time Frame

8 weeks

Title

Serious Adverse Events

Description

Time Frame

8 weeks

Title

Change in stool Bile Acids Composition pre and post FMT

Time Frame

8 Weeks

Title

Changes in stool short chain free fatty acids pre and post FMT

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina Kao, MD

Organizational Affiliation

Associate Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fecal Transplant for Hepatic Encephalopathy

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