Comparison of Bovine Colostrum Versus Placebo in Treatment of Severe Alcoholic Hepatitis: A Randomized Double Blind Controlled Trial (BASH)
Alcoholic Hepatitis
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring Bovine Colostrum, Corticosteriods, Endotoxin, MELD, mDF
Eligibility Criteria
Inclusion Criteria:
- Alcoholic hepatitis Jaundice < 3 months Bilirubin > 5 mg/dl PTI (INR) Increased: >1.4 Leucocytosis >> 11,000/micro L. AST< 300 IU/l ; AST/ALT >2
- Hepatic Encephalopathy
- Men and women age > 18 years and above
- DF>32
- MELD≥21
- Actively consuming alcohol within 6 weeks of entry into the study
- Patient with controlled upper GI bleed, resolved sepsis and acute kidney injury can be enrolled
- Voluntary informed consent
Exclusion Criteria
- Failure to obtain informed consent
- Jaundice more than 3 months
- AST>500 IU/L, ALT>300 IU/L
- Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
- HIV positive
- Cow milk allergy or severe lactose intolerance
- Active Gastrointestinal bleeding
- Acute kidney injury at time of randomization with Creatinine> 1.5 mg/dL
- Evidence of acute pancreatitis or biliary obstruction
- Subjects who are pregnant or lactating
- Significant systemic cardio-pulmonary illness (what if on ventilator for HE or respiratory failure) - These are terminally ill patients, hence be excluded
- Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization
- Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week.
- Any patient who has received any investigational drug or device within 30 days entering into the study.
- Patient who withdraw consent
Sites / Locations
- Department of Gastroenterology, D.M.C. and Hospital
- Ajay Duseja
- Dharmesh Kapoor
- Sandeep Nijhawan
- Shalimar
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Bovine colostrum
Placebo
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
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.