Clinical trial NCT02868164: Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
Official title: Fecal Microbiota Therapy Versus Standard Therapy in Decompensated NASH Related Cirrhosis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: NASH Related Decompensated Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years.
2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
3. 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).
4. No history of recent spontaneous bacterial peritonitis.(1 month)
5. Child Pugh Score of 6 - 10

Exclusion Criteria:

1. Diagnosis of liver disease other than NASH (Non Alcoholic Steatohepatitis) cirrhosis
2. Ongoing bacterial infection requiring antibiotic treatment.
3. Current or history of significant alcohol consumption for a period of more than 3
4. consecutive months within 1 year prior to screening
5. Treatment with antibiotics or probiotics in the preceding 3 months.
6. Inability to safely obtain a liver biopsy in compensated cirrhosis or to perform an upper GastroIntestinal endoscopy
7. Pregnant patients

Primary outcomes:
measure: Number of adverse events complication rate in NASH (Non Alcoholic Steatohepatitis) patients in both groups
timeFrame: 1 year
Secondary outcomes:
measure: Reduction in HVPG (Hepatic Venous Pressure Gradient) in the two groups from baseline at 12 month
timeFrame: 1 year
measure: Improvement in liver function test as compared to baseline in both groups.
timeFrame: 1 year
measure: Improvement in HVPG (Hepatic Venous Pressure Gradient) as compared to baseline in both groups.
timeFrame: 1 year
measure: Improvement duodenal biopsy as compared to baseline in both groups.
timeFrame: 1 year
measure: Improvement in liver stiffness as measured by fibroscan test as compared to baseline in both groups.
timeFrame: 1 year
measure: Improvement in insulin resistance in both groups.
timeFrame: 1 year
measure: Reduction in hepatic and systemic inflammatory markers in both groups
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Kapil Dev Jamwal, DM
role: PRINCIPAL_INVESTIGATOR
References: