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Cow's first milk could be a lifeline for severe Alcohol-Related hepatitis

NCT ID NCT02473341

Disease control Sponsor: Dayanand Medical College and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase 3 trial investigates whether bovine colostrum—the nutrient-rich first milk from cows—can improve survival in people with severe alcohol-associated hepatitis. The condition involves liver inflammation, a leaky gut, and a high risk of infection. Participants receive either colostrum powder or a placebo for four weeks, alongside standard care. The study measures survival at 90 days and changes in liver function and inflammation markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bovine colostrum (freeze-dried powder, 20 grams three times a day for 4 weeks)
What this could lead to
If effective, bovine colostrum could offer a new, affordable treatment to improve survival in severe alcohol-associated hepatitis, a condition with limited options.
What could go wrong
This is a single trial with 174 participants, and previous promising treatments for this condition have failed in larger studies. The benefit may be modest or not statistically significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

174 people

The number who actually took part.

Started

Nov 2017

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria * 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

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Conditions

The condition(s) this trial relates to.

alcoholic hepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcoholic hepatitis

Contacts and locations

Locations

  • All India Institute of Medical Sciences

    New Delhi, India

  • Department of Gastroenterology, Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001, India

  • Department of Hepatology, Global Hospital

    Hyderabad, India

  • Post Graduate Medical Institute of Medical Education and Research

    Chandigarh, India

  • Sawai Man Singh Medical College

    Jaipur, India

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