Efficacy of Combination Therapy of Glucocorticoids and Bovine Colostrum in Treatment of Severe Alcoholic Hepatitis.

Summary

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.

Conditions

• Severe Alcoholic Hepatitis in 'Extremis'- Defined by mDF>54

Interventions

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%.

OTHER

prednisolone

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)

Sponsors & Collaborators

• Dayanand Medical College and Hospital

  lead OTHER

Principal Investigators

• Sandeep S Sidhu, MD,DM · Dayanand Medical College and Hospital

• Omesh Goyal, MD,DM · Dayanand Medical College and Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-05-31

Completion

2015-06-30

Countries

• India

Study Locations