Background Severe alcoholic hepatitis (SAH) is associated with high mortality. Numerous studies and meta-analysis have reported that corticosteroids reduce the 28-day mortality in SAH, but not the 6-month mortality. Therefore, newer treatments for SAH need to be studied. A pilot study from our group had recently treated ten patients with SAH with bovine colostrum (BC) [20 g thrice in a day for 8 weeks] and prednisolone. This therapy improved the biological functions and 3-month mortality. However, as more and more data showed the failure of corticosteroids to improve the 3- and 6-month mortality, especially in patients with high mDF and MELD scores, we planned this trial to study the safety and efficacy of BC (without corticosteroids) in the treatment of SAH. Method This is a multicenter, parallel, double-blind, randomized (1:1) placebo-controlled trial, which will enroll 174 patients with SAH 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, and IL8) levels, number of episodes of sepsis [pneumonia, spontaneous bacterial peritonitis (SBP), cellulitis, urinary tract infection (UTI)] from baseline to 4 weeks. Discussion This study will evaluate the safety and efficacy of bovine colostrum in improving the survival of patients with SAH. Trial registration ClinicalTrials.gov NCT02473341. Prospectively registered on June 16, 2015.
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
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.