A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
NCT ID: NCT03091010
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
112 participants
INTERVENTIONAL
2017-04-08
2020-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fecal Microbiota Transplantation
Fecal Microbiota Transplantation
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
Steroid
Steroids
Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
Interventions
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Fecal Microbiota Transplantation
Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
Steroids
Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
Eligibility Criteria
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Inclusion Criteria
* Eligible for steroid therapy.
Exclusion Criteria
* Active sepsis
* Serum creatinine \> 1.5 mg/dl (Hepato renal syndrome)
* Intestinal paralysis
* Hepatic or extrahepatic malignancy
* Disseminated intravascular coagulation
* Discriminant Function (DF) \>90
21 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Other Identifiers
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ILBS-Alcoholic Hepatitis-01
Identifier Type: -
Identifier Source: org_study_id
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