A Multicentre Double Blind, Placebo Controlled Randomized Trial to Evaluate the Safety and Efficacy of Bovine Colostrum in the Treatment of Severe Alcoholic Hepatitis (SAH).

Abstract

Background Alcoholic Hepatitis (AH) in patients of 2 contemporary Randomized Controlled Trials in India was extremely severe: Maddrey’s Discriminant Function (mDF) [score of 77.4–84 ; MELD of 26–27.5]. The survival rate was very low: 22–30.4%. A pilot study from our group had recently treated ten patients with Severe Alcoholic Hepatitis (SAH) with Bovine colostrum (BC) [20 g thrice in a day for eight weeks] and prednisolone [40 mg once a day for four weeks, tapered over four weeks]. This combo therapy improved the biological function and the survival rate in these extremely sick patients. The aim of this study is to study the safety and efficacy of BC in the treatment of extremely SAH . Method This is a multicenter, parallel, double-blind, randomised (1:1) placebo- controlled trial. Patients will be diagnosed with AH using clinical criteria. Up to 174 participants will be recruited from 5 academic centers in the India. Patients will receive freeze dried BC or placebo by random 1:1 allocation for 4 weeks. The primary outcome measure is survival at 3 months. The secondary outcome measures are survival at 1 month, change in mDF and MELD scores, change in Endotoxin and Cytokines (alpha TNF, IL6 & IL8 ) levels, number of episodes of sepsis (Pneumonia, Spontaneous Bacterial Peritonitis, Cellulitis, Urinary Tract Infection) from baseline to 4 weeks. Discussion This study will confirm the safety and efficacy of Bovine Colostrum in improving the survival of patients with extremely severe SAH . Trial Registration ClinicalTrials.gov Identifier: NCT02473341. Prospectively registered on June 16, 2015 Protocol version: V-4.0