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A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.

NCT03091010 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2020-01-22

No results posted yet for this study

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.

Conditions

  • Severe Alcoholic Hepatitis

Interventions

OTHER

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days

DRUG

Steroids

Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-08
Primary Completion
2019-03-24
Completion
2020-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091010 on ClinicalTrials.gov