Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721264
• Other study ID #: ILBS-NASH-03
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2016
• Last updated: February 13, 2018
• Start date: March 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Abhinav Verma, MD
• Phone: 011-46300000
• Email: abhinav.3183[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Biological:
• Fecal Microbiota Transplant

Other:
• Standard Medical Treatment

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

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