Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

174

Participants

Timeline

Start Date

November 14, 2017

Primary Completion Date

August 1, 2024

Study Completion Date

September 1, 2025

Conditions
Alcoholic Hepatitis
Interventions
DRUG

Bovine Colostrum

"Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a freeze dried powder (20 gm thrice a day) for 4 weeks.~\+ Antibiotics + Diuretics +Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed +drugs for HE if indicated"

DRUG

Placebo

"Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Placebo (Pasteurised Milk Powder) 20 gms thrice a day for 4 weeks~\+ Antibiotics + Diuretics + drugs for HE + Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed + if indicated."

Trial Locations (5)

141001

Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana

Unknown

Post Graduate Medical Institute of Medical Education and Research, Chandigarh

Department of Hepatology, Global Hospital, Hyderabad

Sawai Man Singh Medical College, Jaipur

All India Institute of Medical Sciences, New Delhi

All Listed Sponsors
lead

Dayanand Medical College and Hospital

OTHER