- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02868164
Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
October 30, 2019 updated by: Institute of Liver and Biliary Sciences, India
The study will be conducted in the Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi.
As a part of this study history will be taken and clinical examination will be done.
Subjects will be screened for diagnosis of NASH (Non Alcoholic Steatohepatitis) cirrhosis.
If subjects are found to have NASH (Non Alcoholic Steatohepatitis) cirrhosis, they will be chosen to receive stool from healthy donor, which is voluntarily donated by a healthy donor related or unrelated to the subjects and the stool will be prepared using standard guidelines.
The prepared sample of stool, about 50 ml will be instilled into proximal small intestine by way of a thin and soft tube inserted through nose.
This administration of sample, 50 ml daily will occur once a month every month for 6 months.
The liver function parameters will be assessed and thereafter at 1 month and 3 months & subjects will be clinically assessed for improvement or worsening.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of liver and Biliary Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age more than 18 years.
- All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
- Histological evidence of definite or probable NASH (Non Alcoholic Steatohepatitis) based upon a liver biopsy prior to enrollment and a NAFLD (Non Alcoholic Fatty Liver Disease) activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
- No history of recent spontaneous bacterial peritonitis.(1 month)
- Child Pugh Score of 6 - 10
Exclusion Criteria:
- Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
- Ongoing bacterial infection requiring antibiotic treatment.
- Current or history of significant alcohol consumption for a period of more than 3
- consecutive months within 1 year prior to screening
- Treatment with antibiotics or probiotics in the preceding 3 months.
- Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
- Pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Microbiota Transplantation (FMT)
|
The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
|
Active Comparator: Weight Reduction
|
Standard Treatment
routine exercise for weight reduction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
Time Frame: 1 year
|
Adverse events like GastroIntestinal Bleed, development of ascites, Spontaneous Bacterial peritonitis, ACLF (acute on chronic liver failure)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month
Time Frame: 1 year
|
1 year
|
|
Improvement in liver function test as compared to baseline in both groups.
Time Frame: 1 year
|
1 year
|
|
Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.
Time Frame: 1 year
|
1 year
|
|
Improvement duodenal biopsy as compared to baseline in both groups.
Time Frame: 1 year
|
Improvement is defined as improvement in microbiome pre and post treatment.
|
1 year
|
Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.
Time Frame: 1 year
|
1 year
|
|
Improvement in insulin resistance in both groups.
Time Frame: 1 year
|
Improvement is defined as improvement in the fasting plasma and insulin levels, HOMA-IR
|
1 year
|
Reduction in hepatic and systemic inflammatory markers in both groups
Time Frame: 1 year
|
Hepatic and systemic inflammatory like Tumor Necrosis Factor-α, CRP and serum endotoxins.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr Kapil Dev Jamwal, DM, Institute of liver and Biliary Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2018
Primary Completion (Anticipated)
February 1, 2019
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 13, 2016
First Posted (Estimate)
August 16, 2016
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-Cirrhosis-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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