A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
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|ClinicalTrials.gov Identifier: NCT03091010|
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : October 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Alcoholic Hepatitis||Other: Fecal Microbiota Transplantation Drug: Steroids||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis A Randomized Controlled Trial.|
|Actual Study Start Date :||April 8, 2017|
|Actual Primary Completion Date :||March 24, 2019|
|Actual Study Completion Date :||March 24, 2019|
|Experimental: Fecal Microbiota Transplantation||
Other: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
|Active Comparator: Steroid||
Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
- Proportion of participants with Overall Survival at 3 months [ Time Frame: 3 months ]
- Improvement in Child Pugh Turcotte (score) severity in both groups [ Time Frame: 6 months ]
- Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups [ Time Frame: 6 months ]
- Improvement in Glasgow Alcoholic Hepatitis (score) in both groups [ Time Frame: 6 months ]
- Improvement in Maddrey's Discriminant Function (score) in both groups [ Time Frame: 6 months ]
- Adverse events in both groups [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091010
|Institute of Liver and Biliary Sciences|
|New Delhi, Delhi, India, 110070|