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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Severe Alcoholic Hepatitis

Treatments: Drug: Steroids; Other: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03091010

ILBS-Alcoholic Hepatitis-01

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Fecal Microbiota Transplantation

Experimental group

Treatment:

Other: Fecal Microbiota Transplantation

Steroid

Active Comparator group

Treatment:

Drug: Steroids