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)

Trials · 7 authors, 5 centres

AI SUMMARY

FIDELITY 100%

POPULATIONPatients with severe alcoholic hepatitis (SAH)

INTERVENTIONFreeze-dried bovine colostrum (BC)

COMPARISONPlacebo

This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.

AGENT 01 · STRUCTURED SUMMARY

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TL;DR

This is a planned protocol for a multicenter randomized controlled trial testing bovine colostrum versus placebo in 174 patients with severe alcoholic hepatitis, with the primary goal of evaluating 3-month survival.

Full summary

671 CHARS

This is a protocol for a multicenter, double-blind, randomized, placebo-controlled trial conducted in India to evaluate the safety and efficacy of bovine colostrum (BC) in patients with severe alcoholic hepatitis (SAH). The trial will enroll 174 patients from five academic centers and randomize them 1:1 to receive freeze-dried BC or placebo for 4 weeks. The primary outcome is survival at 3 months. The protocol details statistical methods for analysis, including intention-to-treat analysis for survival outcomes and appropriate tests for other endpoints. This document presents the trial design and methods but reports no results, representing a pre-results protocol.

PICO

PPOPULATION

Patients with severe alcoholic hepatitis (SAH)

IINTERVENTION

Freeze-dried bovine colostrum (BC)

OOUTCOME

Primary: survival at 3 months; Secondary: survival at 1 month, change in mDF/MELD scores, endotoxin and cytokine levels, sepsis episodes.

STUDY TYPE

other

SPECIALTY

gastroenterology

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10416362

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)

Trials

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ABSTRACT

Abstract 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. Supplementary Information The online version contains supplementary material available at 10.1186/s13063-023-07505-8.

CITATION EXPORT

S S Sidhu, A Dusseja, Shalimar et al.. 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). Trials. (2023). https://doi.org/10.1186/s13063-023-07505-8

AUTHORS

7 · 5 CENTRES

S S Sidhu, A Dusseja, Shalimar, S Nijhawan, D Kapoor, O Goyal, H Kishore

1Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab India
2Department of Hepatology, Post Graduate Institute of Medical Education & Research, Chandigarh, India
3Department of Gastroenterology & Human Nutrition Unit, All India Institute of Medical Sciences, Delhi, India
4Department of Gastroenterology, Sawai Man Singh Hospital, Jaipur, India
5Department of Hepatology, Global Hospital, Hyderabad, India