Back to resultsA Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
Primary Purpose
Severe Alcoholic Hepatitis
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Steroids
Sponsored by
About this trial
This is an interventional treatment trial for Severe Alcoholic Hepatitis
Eligibility Criteria
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
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fecal Microbiota Transplantation
Steroid
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants with Overall Survival at 3 months
Secondary Outcome Measures
Improvement in Child Pugh Turcotte (score) severity in both groups
Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups
Improvement in Glasgow Alcoholic Hepatitis (score) in both groups
Improvement in Maddrey's Discriminant Function (score) in both groups
Adverse events in both groups
Full Information
NCT ID
NCT03091010
First Posted
March 9, 2017
Last Updated
January 21, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT03091010
Brief Title
A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
Official Title
A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 8, 2017 (Actual)
Primary Completion Date
March 24, 2019 (Actual)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Alcoholic Hepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal Microbiota Transplantation
Arm Type
Experimental
Arm Title
Steroid
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
Intervention Type
Drug
Intervention Name(s)
Steroids
Intervention Description
Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
Primary Outcome Measure Information:
Title
Proportion of participants with Overall Survival at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement in Child Pugh Turcotte (score) severity in both groups
Time Frame
6 months
Title
Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups
Time Frame
6 months
Title
Improvement in Glasgow Alcoholic Hepatitis (score) in both groups
Time Frame
6 months
Title
Improvement in Maddrey's Discriminant Function (score) in both groups
Time Frame
6 months
Title
Adverse events in both groups
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
We'll reach out to this number within 24 hrs