Clinical Research Directory

Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis

Sponsor: Dayanand Medical College and Hospital

Summary

Severe Alcohol-associated hepatitis, is associated with significant morbidity and mortality.1,2 Of the various treatment modalities evaluated for treatment of Severe Alcoholic hepatitis, corticosteroids have been the most extensively studied.1 Five out of 13 randomized controlled trials, and four out of 5 meta-analysis have shown a survival benefit with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.1-4 However, the role of corticosteroidsin Severe Alcoholic hepatitis still remains controversial.5-6Corticosteroid therapy is not considered the ideal option by mostauthors because their beneficial effect seems to be confined to a highly select minority group in which the inhibitory effect of corticosteroids on liverinflammation is not outweighed by side effects such as weakened defence against infections, anti-anabolic effects, and possible ulcer promoting effects.6Corticosteroids are usually contraindicated in those with DF \> 54 or MELD \>247 .Also corticosteroidsare contraindicated in those with renal failure, gastro-intestinal bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to evaluate new therapies for Severe Alcoholic hepatitis (SAH). In a recent trial, combination of glucocorticoids plus N-acetylcysteine was found to improve one month survival in patients with Severe Alcoholic hepatitis, compared with glucocorticoids alone. However, the 6 month survival similar in both the groups.8 Human colostrum and bovine colostrum are rich in protein, immunoglobulin, lactoferrin and growth factors. Recent studies suggest that colostrum components, immunoglobulin and growth factor benefits physically active personas well as in the treatment of autoimmune disorders. It is used for the treatment of a wide variety of gastrointestinal conditions, including non-steroidal anti-inflammatorydrug-induced gut injury, Helicobacter pylori infection, immune deficiency related diarrhea as well as infective diarrhea.9,10,11It has also been sucessfully used to significantly decrease the level of Endotoxemia - lower levels of Lipopolysaccharides. We plan to compare the efficacy of bovine colostrum versus Placebo (Pasteurized milk powder) alone in treatment of severe alcoholic hepatitis.

Official title: Efficacy Of Bovine Colostrum In The Treatment Of Severe Alcohol-Associated Hepatitis: A Double Blind Multicentric Randomized Controlled Trial

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