Status:
UNKNOWN
Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis- Assessment of Impact on Prognosis and Short-term Outcome
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Severe Alcoholic Hepatitis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Alcoholic liver disease has become one of the foremost causes of chronic liver disease across the world, and a cause of considerable morbidity and mortality. Alcoholic steatohepatitis is an entity in ...
Eligibility Criteria
Inclusion
- Severe alcoholic hepatitis will be defined as proposed by the American College of Gastroenterology
- Rapid development or worsening of jaundice and liver-related complications with serum total bilirubin more than 3 milligrams per decilitre.
- Aspartate aminotransferase and alanine aminotransferase elevated to more than one and half times the upper limit of normal, but less than 400 IU per litre, with AST to ALT ratio over 1.5.
- Documentation of persistent heavy alcohol use until 8 weeks before onset of symptoms.
- Alcohol Consumption in female over 40 grams per day for at least 6 months and in males over 60 grams per day for at least 6 months.
- Maddrey's Discriminant Function Score of more than 32 OR
- A patient of alcoholic hepatitis who will present with grade 1 or 2 of hepatic encephalopathy.
Exclusion
- Intestinal paralysis, lack of bowel sounds, intestinal perforation.
- Uncontrolled infections.
- Uncontrolled upper gastrointestinal bleeding.
- Grade 3,4 hepatic encephalopathy.
- Hepatic or extrahepatic malignancy.
- Maddrey's Discriminant Function (mDF) \>90 or MELD\>30.
- Autoimmune hepatitis, Wilson's disease, suspected drug induced liver injury.
- Patients who are aged \>60 years
- WBC count \<1000 cells/mm3
- Pregnancy or nursing.
- Human Immunodeficiency Virus (HIV), HBV, HCV infection.
- Patient's unwillingness to participate in the study.
- Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03827772
Start Date
January 1 2019
End Date
December 1 2019
Last Update
February 1 2019
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012