Severe Alcoholic Hepatitis
Conditions
Brief summary
Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences. Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days. Monitoring and assessment: The recipient will be monitored every day after Fecal Microbiota Transplantation therapy. The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy. Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 & 180.
Interventions
OTHERFecal Microbiota Transplantation
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
DRUGSteroids
Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with severe alcoholic hepatitis . * Eligible for steroid therapy.
Exclusion criteria
* Upper gastrointestinal bleed within the past one month. * Active sepsis * Serum creatinine \> 1.5 mg/dl (Hepato renal syndrome) * Intestinal paralysis * Hepatic or extrahepatic malignancy * Disseminated intravascular coagulation * Discriminant Function (DF) \>90
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with Overall Survival at 3 months | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Child Pugh Turcotte (score) severity in both groups | 6 months |
| Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups | 6 months |
| Improvement in Glasgow Alcoholic Hepatitis (score) in both groups | 6 months |
| Improvement in Maddrey's Discriminant Function (score) in both groups | 6 months |
| Adverse events in both groups | 6 months |
Countries
India
Outcome results
None listed