Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: Fecal microbiota transplantation: 30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.
Control Intervention1: Standard of care tre
Sponsors
PGIMER
Dr Ajay Duseja
Dr Madhumita Premkumar
Dr Nipun Verma
Dr Sandeep Grover
Dr Sunil Taneja
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MortalityTimepoint: 1 month, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 5. Improvement in CLIF SOFA Score(Chronic Liver Failure Sequential Organ Failure Assessment) score.Timepoint: 1 month, 3 months;Changes in inflammatory markers (IL1b, IL6, TNF α) 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 | — |
Countries
India
Contacts
Public ContactAnima Sharma
PGIMER
Outcome results
None listed