Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

A multicenter double-blind, placebo-controlled randomized trial to evaluate the safety and efficacy of bovine colostrum in the treatment of severe alcoholic hepatitis (SAH).

  • 2023-08-11
  • Trials 24(1)
    • S S Sidhu
    • A Dusseja
    • Shalimar
    • S Nijhawan
    • D Kapoor
    • O Goyal
    • H Kishore

Study Design

Type
Meta-Analysis
Sample size
n = 174
Population
174 patients with severe alcoholic hepatitis (SAH) from 5 academic centers in India
Methods
multicenter, parallel, double-blind, randomized (1:1) placebo-controlled trial; patients receive freeze-dried bovine colostrum or placebo for 4 weeks
Blinding
Double-blind
Duration
4 weeks

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.

Research Insights

Back to top