Clinical trial NCT02721264: Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.
Official title: Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.


Eligibility criteria: Inclusion Criteria:

1. Age more then 18 years.
2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
3. Histologic evidence of definite or probable NASH based upon a liver biopsy prior to enrollment and a NAFLD 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 past history of upper GI bleeding, ascites, hepatic encephalopathy

Exclusion Criteria:

1. Diagnosis of liver disease other than NASH cirrhosis
2. History of gastrointestinal bleeding, ascites, hepatic encephalopathy
3. Ongoing bacterial infection requiring antibiotic treatment.
4. Current or history of significant alcohol consumption for a period of more than 3 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 or perform an upper GI endoscopy
7. Psychiatric disorder
8. HIV
9. Pregnant women
10. Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis

Primary outcomes:
measure: Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in liver function test as compared to baseline.
timeFrame: 1 year
measure: Improvement in Liver Stiffness Measurement as compared to baseline.
timeFrame: 1 year
measure: Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)
timeFrame: 1 year
measure: Incidence of new onset upper gastrointestinal bleed in both groups
timeFrame: 1 year
measure: development of new onset of ascites in both groups.
timeFrame: 1 year
measure: Number of Spontaneous Bacterial peritonitis cases in both groups.
timeFrame: 1 year
measure: ACLF (Acute on Chronic Liver failure) cases in both groups.
timeFrame: 1 year
measure: Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups
timeFrame: 1 year
measure: Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups
timeFrame: 1 year
measure: Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.
timeFrame: 1 year
measure: Histological and permeability changes in the duodenal biopsy in both groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Abhinav Verma, MD
role: PRINCIPAL_INVESTIGATOR
References: