Efficacy of Combination Therapy of Glucocorticoids and Bovine Colostrum in Treatment of Severe Alcoholic Hepatitis. (COBS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02265328|
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : September 15, 2015
Severe Alcoholic hepatitis (SAH), defined by modified Maddrey's Discriminant Function (DF) ≥32, is associated with significant morbidity and mortality. Of the various treatment modalities evaluated for treatment of SAH, corticosteroids have been the most extensively studied. Five out of 13 RCTs, and four out of 5 meta-analysis have shown a survival benefit with corticosteroids, especially in patients with DF ≥32 and/ or encephalopathy.However, the role of corticosteroids in SAH still remains somewhat controversial. Corticosteroid therapy is not considered the ideal option by all authors because their beneficial effect seems to be confined to a highly selected minority group in which the inhibitory effect of corticosteroids on liver inflammation is not outweighed by side effects such as weakened defence against infections, anti-anabolic effects, and possible ulcer promoting effects. Also corticosteroids are contraindicated in patients with renal failure, gastro-intestinal (GI) bleed, pancreatitis and active sepsis. Therefore, there have been constant efforts to evaluate new therapies for SAH. In a recent trial, combination of glucocorticoids plus N-acetylcysteine was found to improve one month survival in patients with SAH, compared with glucocorticoids alone. However the 6 month survival was not different in both groups.
Human Colostrum (HC) and Bovine Colostrum (BC) are rich in protein, immunoglobulin, lactoferrin and growth factors. Recent studies suggest that colostrum components, Lactroferrin, immunoglobulin and growth factor benefits physically active person and in treatment of autoimmune disorders. It is used for the treatment of a wide variety of gastrointestinal conditions, including non-steroidal anti-inflammatory drug-induced gut injury, H pylori infection, immune deficiency related diarrhea as well as infective diarrhea.
The guidelines by American College of Gastroenterology and other authors have suggested that a combination of CS and other drugs, which have different mechanisms of action, may be more beneficial for reducing mortality in SAH. Hence, we plan to conduct this pilot study to investigate the efficacy of a novel combination of corticosteroids, and Bovine colostrum in the treatment of SAH.
|Condition or disease||Intervention/treatment||Phase|
|Severe Alcoholic Hepatitis in 'Extremis'- Defined by mDF>54||Dietary Supplement: Bovine colostrum Dietary Supplement: Enteral Nutrition Other: prednisolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Combination Therapy of Glucocorticoids, and Bovine Colostrum in Treatment of Severe Alcoholic Hepatitis: A Pilot Study.|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Bovine colostrum + prednisolone
Dietary Supplement: Bovine colostrum
Oral Bovine colostrum 200 ml (20 gram) TDS × 2 months
Dietary Supplement: Enteral Nutrition
Enteral nutrition: Protein 1.5 gm/kg/day, energy (kcal) 40/kg/day, carbohydrate 67-80%, Fat 20-33%.
Oral prednisolone 40mg/day × 4 weeks and tapered to <40mg/day for next 4 weeks. (If Lilli score > 0.45 after 7 days, then prednisolone would be stopped)
Other Name: Wysolone, Predicort
- Change in mDf Value from baseline to 8 weeks [ Time Frame: 2 month ]
- Change in Endotoxin level from baseline to 8 weeks [ Time Frame: 2 month ]
- Cytokines Levels (αTNF, IL 6, IL 8) from baseline to 8 weeks. [ Time Frame: 2 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265328
|Dyanand Medical College and Hospital|
|Ludhiana, Punjab, India, 141001|
|Principal Investigator:||Sandeep S Sidhu, MD,DM||Dayanand Medical College and Hospital|
|Principal Investigator:||Omesh Goyal, MD,DM||Dayanand Medical College and Hospital|