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

NCT02473341 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: DMCH/R&D/2017/578
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 5

Brief Summary

Severe alcohol-associated hepatitis is associated with hepatocellular necrosis, inflammation, hyperactivated immune system, paradoxical immune exhaustion, leaky gut, and alteration in the gut microbiome. The leading cause of mortality is a bacterial infection with multi-organ failure. Pentoxifylline was ineffective and Interleukin-1-based therapies - Anakinra and Canakinumab have not improved survival rates. The granulocyte colony-stimulating factor has shown mixed results. Indian studies improved 90-day survival, while Western studies on Pegfilgrastim have been negative. Corticosteroids decrease the mortality for only a month. In a recent study on Severe alcohol-associated hepatitis, Larsucosterol, a DNA methyltransferase inhibitor, was associated with non-significant improvement in 90-day mortality: 14.7 % (30 mg/day) and 16.67 % (90 mg/day) versus 24.27% on Methylprednisolone. Thus, a more durable treatment of severe alcohol-associated hepatitis is needed. Bovine Colostrum contains many bioactive components such as immunoglobulin G, A, and M (70 - 80 % of total protein), Lactoferrin and Short-chain fatty acids. Bovine Colostrum has 30-100 times higher Lactoferrin concentration than milk. IgG and Lactoferrin synergistically neutralise lipopolysaccharide/ Endotoxin and act on mucosa-associated lymphoid tissue of the leaky gut, transforming it into healthy mucosa. Fewer bacteria and Endotoxins - Pathogen-associated molecular patterns enter the portal circulation to interact with Toll-Like Receptor - 4 of the Liver Kupffer cells. Proinflammatory cytokines such as interleukins-1,6,8 and tumour necrosis factor-alpha, generation decreases, mitigating hepatocyte inflammation, necrosis, and cell death. In this study, we aimed to assess the effectiveness and safety of Gut-Liver Axis Modulation with IgG-Enriched Oral Immunotherapy(Bovine Colostrum) in Severe Alcohol-Associated Hepatitis

Conditions

Alcoholic Hepatitis

Keywords

Bovine Colostrum; Endotoxin; MELD; mDF; Alpha TNF

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival at 3 month

  3 month

Secondary Outcomes (5)

• Change in mDF and MELD levels

  one month

• Change in Endotoxin levels

  one month

• Change in Cytokines levels

  one month

• Number of episodes of sepsis

  1 month

• Survival

  1 month

Study Arms (2)

Bovine colostrum

EXPERIMENTAL

Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a lyophilised 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: Bovine Colostrum

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Bovine Colostrum DRUG

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

Bovine colostrum

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Onset of jaundice within prior 8 weeks
• Ongoing consumption of \> 40 (female) or 60 (males) g alcohol/day for 6 months or more, with less than 60 days of abstinence before the onset of jaundice
• Aspartate aminotransferase \> 50, aspartate aminotransferase/alanine aminotransferase \> 1.5, and both values \< 400 IU/L
• Serum bilirubin (total) \> 3.0 mg/dL
• Liver biopsy confirmation in patients with confounding factors including possible ischemic hepatitis (eg, severe upper gastrointestinal bleed, hypotension, or cocaine use within 7 days); possible DILI; uncertain alcohol use assessment (eg, patient denies excessive alcohol use); and atypical laboratory tests (eg, AST \< 50 IU/mL or \> 400 IU/mL, AST/ALT ratio \< 1.5), antinuclear antibody \> 1:160 or SMA \> 1:80
• Maddrey's discriminant function ≥ 32 assuming a control prothrombin time of 12 seconds
• Model for End-stage Liver Disease score \> 20

You may not qualify if:

• Uncontrolled infections
• Multiorgan failure
• Uncontrolled upper gastrointestinal bleeding. "However, patients with recent Upper Gastro Intestinal bleeding, without significant hypotension that is controlled for \>48 hours, will be included in the study."
• Preexisting kidney injury with serum creatinine \> 2.5 mg/dL
• Other underlying liver diseases including hepatitis B infection,\* autoimmune liver diseases, Wilson disease, suspected drug-induced liver injury\*
• Hepatocellular carcinoma or other active malignancies except skin cancer
• Pregnancy
• Uncontrolled drug addiction
• Cow milk allergy or severe lactose intol

Sponsors & Collaborators

• Dayanand Medical College and Hospital: lead

Study Sites (5)

Department of Gastroenterology, Dayanand Medical College and Hospital

Ludhiana, Punjab, 141001, India

Location

Post Graduate Medical Institute of Medical Education and Research

Chandigarh, India

Location

Department of Hepatology, Global Hospital

Hyderabad, India

Location

Sawai Man Singh Medical College

Jaipur, India

Location

All India Institute of Medical Sciences

New Delhi, India

Location

Related Publications (40)

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MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Sandeep Singh Sidhu, DM

  Dayanand Medical College and Hospital, Ludhiana, Punjab, India

  PRINCIPAL INVESTIGATOR

• Ajay Duseja, DM

  PGI Hospital, Chandigarh, India

  PRINCIPAL INVESTIGATOR

• Shalimar S, DM

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dharmesh Kapoor

  Gleneagles Global Hospital, Hyderabad

  PRINCIPAL INVESTIGATOR

• Sandeep Nijhawan

  SMS Hospital, Jaipur, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Sandeep Singh Sidhu

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 16, 2015
• Study Start: November 14, 2017
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

IN (5)