Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Not Applicable

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Biological: Fecal Microbiota Transplant; Other: Standard Medical Treatment

• Registration Number: NCT02721264
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation (FMT)	Fecal Microbiota Transplant	The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 5 month.
Standard Treatment Care	Standard Medical Treatment	-

Primary Outcome Measures

Name	Time	Method
Reduction in Hepatic Venous Pressure Gradient in the two groups from baseline.	1 year

Secondary Outcome Measures

Name	Time	Method
Histological and permeability changes in the duodenal biopsy in both groups.	1 year
Incidence of new onset upper gastrointestinal bleed in both groups	1 year
development of new onset of ascites in both groups.	1 year
Improvement in Liver Stiffness Measurement as compared to baseline.	1 year	LSM \< 10 Kpa
Assess improvement in insulin resistance (Fasting plasma and insulin levels, HOMA-IR)	1 year	HOMA IR \<2.5
Improvement in liver function test as compared to baseline.	1 year	Improvement is defined as Serum bilirubin,AST,ALT,serum Albumin within normal limits
Number of Spontaneous Bacterial peritonitis cases in both groups.	1 year
Reduction in hepatic and systemic inflammatory markers like TNF-α in both groups	1 year
Reduction in hepatic and systemic inflammatory markers like C Reactive Protein in both groups	1 year
ACLF (Acute on Chronic Liver failure) cases in both groups.	1 year
Reduction in hepatic and systemic inflammatory markers like serum endotoxins in both groups.	1 year

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India