Active — Not RecruitingPhase 3

Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Randomized Controlled Trial

India174 participantsStarted 2017-11-14

Plain-language summary

Severe alcohol-associated hepatitis (sAH)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. We therefore conducted a multicenter, phase 3, double-blind, randomized, placebo-controlled trial to determine whether Bovine Colostrum, in addition to standard medical therapy, improves 90-day survival among patients with sAH. Secondary objectives were to assess its effects on liver disease severity, endotoxemia, systemic inflammatory markers, sepsis, and safety.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 canc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Survival

Timeframe: 3 month

Trial details

NCT IDNCT02473341

SponsorDayanand Medical College and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

View on ClinicalTrials.gov More Alcoholic Hepatitis trials