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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation | Experimental |
| |
| Steroid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Other | Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with Overall Survival at 3 months | 3 months |
| Measure | Description | 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Steroids | Drug | Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis |
|
| 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 |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |