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

Severe Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03091010
• Other study ID #: ILBS-Alcoholic Hepatitis-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 8, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: June 30, 2020
• Est. primary completion date: March 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Severe Alcoholic Hepatitis

Intervention

Other:
• Fecal Microbiota Transplantation
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days

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

Locations

Country	Name	City	State
India	Institute of Liver and 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	Proportion of participants with Overall Survival at 3 months		3 months
Secondary	Improvement in Child Pugh Turcotte (score) severity in both groups		6 months
Secondary	Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups		6 months
Secondary	Improvement in Glasgow Alcoholic Hepatitis (score) in both groups		6 months
Secondary	Improvement in Maddrey's Discriminant Function (score) in both groups		6 months
Secondary	Adverse events in both groups		6 months