Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: 1.nasojejunal route (FMT NJ)
2. colonoscopic route (FMT COL)
: 1. Nasojejunal (NJ) FMT
Placement of nasojejunal tube under standard aseptic precautions
Radiological confirmation of
Sponsors
Jivanu Therapeutics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18 80 years. 2.Diagnosis of Severe Alcoholic Hepatitis defined by: Clinical Criteria Recent onset jaundice within 8 weeks History of significant alcohol intake: Greater than 40 g/day (women) or Greater than60 g/day (men) for Greater than or Equal to 6 months Less than 60 days abstinence prior to admission Laboratory Criteria Serum bilirubin Greater than or Equal to3 mg/dL AST 50 400 U/L AST/ALT ratio Greater than 1.5 ALT Less than 300 U/L Exclusion of alternate etiologies Viral hepatitis A E Autoimmune hepatitis Drug-induced liver injury Ischemic hepatitis or biopsy proven alcoholic hepatitis. Biliary obstruction or biopsy proven alcoholic hepatitis. 3.Severity defined by at least one: Maddrey s Discriminant Function (MDF)Greater than or Equal to 32 OR MELD score Greater than 20 4.Fit to undergo both colonoscopy and NJ tube placement. Informed consent from patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1.Active sepsis with hemodynamic instability 2.Active gastrointestinal bleeding within 5 days 3.ACLF Grade 3 or established multi-organ failure 4.Intestinal obstruction, perforation, or contraindication to colonoscopy 5.Known HIV infection with uncontrolled viremia 6.Pregnancy or breastfeeding 7.Prior FMT within 3 months 8.Advanced malignancy or comorbidity limiting 90-day survival
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90 day overall survival following randomization among patients with SAH receiving one of the following interventions Arm A FMT via nasojejunal NJ route Arm B FMT via colonoscopic route Arm C Standard corticosteroid therapy Survival will be defined as survival status at 90 days from the date of randomization irrespective of the cause of death Timepoint: BASELINE 7 28 60 AND 90 DAYS | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Disease Severity Scores Changes in disease severity will be assessed at Days 7 28 90 including Model for End Stage Liver Disease MELD score Maddreys Discriminant Function MDF Glasgow Alcoholic Hepatitis Score GAHS Timepoint: DAY 90;Donor Microbiota Engraftment Donor microbiota engraftment following FMT will be assessed among participants receiving FMT FMT NJ FMT COL by comparing donor recipient microbiome similarity over time using metagenomic sequencing based microbiome profiling including Alpha diversity indices e g Shannon diversity index Beta diversity analysis using ordination methods such as principal coordinate analysis PCoA Donor microbial strain engraftment patterns assessed by similarity between donor recipient microbiome profiles at Day 7 Day 14 Day 28 Day 90 Timepoint: Day 7 14 28 90;Infection Outcomes Incidence of bacterial fungal infections during the follow up period including Spontaneous bacterial peritonitis Pneumonia Bacteraemia Sepsis Timepoint: DAY 90;Renal Outcomes Development of acute kidney injury AKI Requirement for renal replacement therapy Timepoint: Days 7 28 90;Incidence of grade of Hepatic Encephalopathy Timepoint: DAY 90;Hospital Related Outcomes Duration of hospital stay 90 day readmission rate Timepoint: Day 90;Safety Outcomes Procedure related FMT attributable corticosteriod therapy attributable adverse events including Aspiration events in the NJ arm Colonoscopy related complications such as perforation or bleeding Gastrointestinal intolerance Adverse events related to corticosteroid therapy Other procedure related adverse events Timepoint: Days 7 28 90;Alcohol Abstinence Alcohol abstinence at Day 90 assessed by Self reported abstinence Biochemical markers PEth test where feasible Timepoint: Day 90 | — |
Countries
India
Contacts
Public ContactDr ANAND V KULKARNI
AIG HOSPITALS
Outcome results
None listed