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

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ClinicalTrials.gov Identifier: NCT02265328
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital

Brief 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Bovine colostrum + prednisolone
  1. Enteral nutrition: Protein 1.5 gm/kg/day, energy (kcal) 40/kg/day, carbohydrate 67-80%, Fat 20-33%.
  2. Oral prednisolone 40mg/day × 4 weeks and tapered to <40mg/day for next 4 weeks. If Lilli score > 0.45 after 7 days, then GC would be stopped and patients will be counselled for liver transplantation.
  3. Oral Bovine colostrum (200 ml (20 gram) TDS × 2 months.
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)
Other Name: Wysolone, Predicort




Primary Outcome Measures :
  1. Change in mDf Value from baseline to 8 weeks [ Time Frame: 2 month ]

Secondary Outcome Measures :
  1. Change in Endotoxin level from baseline to 8 weeks [ Time Frame: 2 month ]
  2. Cytokines Levels (αTNF, IL 6, IL 8) from baseline to 8 weeks. [ Time Frame: 2 month ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Severe Alcoholic hepatitis (mDF > 54)
  2. Age 18-65 Year

4. Actively consuming alcohol within 6 weeks of entry into the study

Exclusion Criteria:

  1. Failure to obtain informed consent
  2. Active infection or sepsis
  3. Other concomitant causes of liver disease: viral hepatitis, autoimmune liver disease, metabolic liver disease, vascular liver disease
  4. HIV positive
  5. Cow milk allergy or severe lactose intolerance
  6. Active Gastrointestinal bleeding
  7. Acute kidney injury at time of randomization with Creatinine > 1.5 mg/dL
  8. Evidence of acute pancreatitis or biliary obstruction
  9. Subjects who are pregnant or lactating
  10. Significant systemic cardio-pulmonary illness
  11. Patients requiring the use of vasopressors or inotropic support in 12 hours prior to randomization
  12. Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids use>1 week.
  13. Any patient who has received any investigational drug or device within 30 days entering into the study

Information from the National Library of Medicine

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


Locations
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India
Dyanand Medical College and Hospital
Ludhiana, Punjab, India, 141001
Sponsors and Collaborators
Dayanand Medical College and Hospital
Investigators
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Principal Investigator: Sandeep S Sidhu, MD,DM Dayanand Medical College and Hospital
Principal Investigator: Omesh Goyal, MD,DM Dayanand Medical College and Hospital

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Responsible Party: Prof. Sandeep S Sidhu, Prof. Sandeep S sidhu, Dayanand Medical College and Hospital
ClinicalTrials.gov Identifier: NCT02265328    
Other Study ID Numbers: COBS-2014
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital:
Severe Alcoholic Hepatitis in 'Extremis'
Bovine Colostrum
Glucocorticoids
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics