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

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

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.

Study Overview

• Status: Unknown
• Conditions: Severe Alcoholic Hepatitis
• Intervention / Treatment: Other: Fecal Microbiota Transplantation; Drug: Steroids

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fecal Microbiota Transplantation	Other: Fecal Microbiota Transplantation; Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
Active Comparator: Steroid	Drug: Steroids; Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants with Overall Survival at 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in Child Pugh Turcotte (score) severity in both groups	6 months
Improvement in Model for End Stage Liver Disease (MELD) of liver disease 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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2017
• Primary Completion (Actual): March 24, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Hepatitis; Hepatitis A; Hepatitis, Alcoholic
• Other Study ID Numbers: ILBS-Alcoholic Hepatitis-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No