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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
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.


Condition or disease Intervention/treatment Phase
Severe Alcoholic Hepatitis Other: Fecal Microbiota Transplantation Drug: Steroids Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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




Primary Outcome Measures :
  1. Proportion of participants with Overall Survival at 3 months [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Improvement in Child Pugh Turcotte (score) severity in both groups [ Time Frame: 6 months ]
  2. Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups [ Time Frame: 6 months ]
  3. Improvement in Glasgow Alcoholic Hepatitis (score) in both groups [ Time Frame: 6 months ]
  4. Improvement in Maddrey's Discriminant Function (score) in both groups [ Time Frame: 6 months ]
  5. Adverse events in both groups [ Time Frame: 6 months ]


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03091010     History of Changes
Other Study ID Numbers: ILBS-Alcoholic Hepatitis-01
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders