A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.

Not Applicable

• Conditions: Severe Alcoholic Hepatitis
• Interventions: Other: Fecal Microbiota Transplantation; Drug: Steroids

• Registration Number: NCT03091010
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences.

Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days.

Monitoring and assessment:

The recipient will be monitored every day after Fecal Microbiota Transplantation therapy.

The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy.

Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 \& 180.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-27
• Study Start: 2017-04-08
• Primary Completion: 2019-03-24
• Status Verified: 2019-10
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22
• Study Completion: 2020-06-30

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with severe alcoholic hepatitis .
• Eligible for steroid therapy.

Exclusion Criteria

• Upper gastrointestinal bleed within the past one month.
• Active sepsis
• Serum creatinine > 1.5 mg/dl (Hepato renal syndrome)
• Intestinal paralysis
• Hepatic or extrahepatic malignancy
• Disseminated intravascular coagulation
• Discriminant Function (DF) >90

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal Microbiota Transplantation	Fecal Microbiota Transplantation	-
Steroid	Steroids	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with Overall Survival at 3 months	3 months

Secondary Outcome Measures

Name	Time	Method
Improvement in Child Pugh Turcotte (score) severity in both groups	6 months
Improvement in Glasgow Alcoholic Hepatitis (score) in both groups	6 months
Improvement in Maddrey's Discriminant Function (score) in both groups	6 months
Adverse events in both groups	6 months
Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups	6 months

Trial Locations

Locations (1)

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