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

Hepatic Encephalopathy Clinical Trial

Official title:

A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255617
• Other study ID #: 47057
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 23, 2014
• Est. completion date: September 23, 2019

Study information

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

Clinical Trial 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.

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 and Stroop as well as serum ammonia levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 23, 2019
• Est. primary completion date: July 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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

2. abnormal inhibitory control test, defined as greater than 5 lures.

3. an infectious etiology which may cause HE has been ruled out

Exclusion Criteria:

1. those with tense ascites

2. those who do not provide assent

3. those who are judged to have a life expectancy of less than 3 months,

4. those who had TIPS within 3 months,

5. those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions

6. pregnancy

7. those with intestinal obstruction

8. those with alcoholic hepatitis

9. those with active alcohol or substance abuse

10. those without stable social support

11. those who have a concurrent infection, such as SBP, pneumonia or UTI

12. those with creatinine clearance less than 50% compared to baseline

13. those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Biological:
• Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donors

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portion of participants with normailzation 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		8 weeks
Secondary	Changes in Intestinal Microbiota pre and post FMT		8 weeks
Secondary	Serious Adverse Events	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	Changes in stool bile acids composition pre and post FMT		8 Weeks
Secondary	Changes in stool short chain fatty acids pre and post FMT		8 weeks