Fecal Transplant for Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439982
• Other study ID #: Pro00060782
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 12, 2016
• Est. completion date: March 18, 2021

Study information

• Verified date: July 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 18, 2021
• Est. primary completion date: August 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Biological:
• FMT
FMT processed from routinely screened donors

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Rebiotix Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portion of participants with normalization of ICT or Stroop Test during the study		8 weeks
Secondary	Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8		8 weeks
Secondary	Changes in serum ammonia level pre and post FMT		8 weeks
Secondary	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	8 weeks
Secondary	Change in Intestinal Microbiota pre-and post FMT		8 weeks
Secondary	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.	8 weeks
Secondary	Change in stool Bile Acids Composition pre and post FMT		8 Weeks
Secondary	Changes in stool short chain free fatty acids pre and post FMT		8 weeks