A clinical trial to evaluate fecal microbiota transplantation in the treatment of patients with severe alcoholic hepatitis.

Not Applicable

Conditions: Health Condition 1: K701- Alcoholic hepatitis

Registration Number: CTRI/2019/02/017538

Lead Sponsor: PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Alcoholic hepatitis, as defined by:

1. Rapid development or worsening of jaundice and liver-related complications with serum total bilirubin more than 3 milligrams per decilitre.

2.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.

3.Documentation of persistent heavy alcohol use until 8 weeks before onset of symptoms.

4.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.

5.Maddreys Discriminant Function Score of more than 32 OR

6.A patient of alcoholic hepatitis who will present with grade 1 or 2 of hepatic encephalopathy.

Exclusion Criteria

1. Intestinal paralysis, lack of bowel sounds, intestinal perforation.

2.Uncontrolled infections.

3.Uncontrolled upper gastrointestinal bleeding.

4.Grade 3,4 hepatic encephalopathy.

5.Hepatic or extrahepatic malignancy.

6.Maddreyâ??s Discriminant Function (mDF) >90 or MELD >30.

7.Autoimmune hepatitis, Wilsonâ??s disease, suspected drug induced liver injury.

8.Patients who are aged >60 years

9.WBC count <1000 cells/mm3

10.Pregnancy or nursing.

11.Human Immunodeficiency Virus (HIV), HBV, HCV infection.

12.Patientâ??s unwillingness to participate in the study.

13.Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MortalityTimepoint: 1 month, 3 months

Secondary Outcome Measures

Name	Time	Method
5.Improvement in CLIF SOFA Score(Chronic Liver Failure Sequential Organ Failure <br/ ><br>Assessment) score.Timepoint: 1 month, 3 months;Changes in inflammatory markers (IL1b, IL6, TNF Î±) pre and post FMT.Timepoint: baseline, 1 month;Improvement in CTP (Child Turcotte Pugh Score) scoreTimepoint: 1 month, 3 months;Improvement in MELD (Model for End Stage Liver Disease) score.Timepoint: 1 month, 3 months;Improvement in MELD Na (Model for End Stage Liver Disease Sodium) score.Timepoint: 1 month, 3 months;Safety of fecal microbiota transplantation in patients with SAH.Timepoint: 3 months