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Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis- Assessment of Impact on Prognosis and Short-term Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03827772
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Radha K Dhiman, Postgraduate Institute of Medical Education and Research

Brief Summary:

Alcoholic liver disease has become one of the foremost causes of chronic liver disease across the world, and a cause of considerable morbidity and mortality. Alcoholic steatohepatitis is an entity in this broad spectrum, with severe alcoholic hepatitis transitioning to acute on chronic liver failure carrying a one month mortality of as high as 20 to 50%.

The current management guidelines for severe alcoholic hepatitis show benefit with prolonged alcohol abstinence, nutritional support, the use of corticosteroids, pentoxifylline or N-acetyl cysteine (NAC) and early liver transplantation. However, major studies and meta-analyses have demonstrated that these interventions, with the exception of early liver transplantation, do not improve mortality rates to the level of statistical significance. Owing to the high short term mortality associated with severe alcoholic hepatitis, the inadequacy of a treatment that could significantly impact this short term mortality, and the limited applicability of early liver transplantation, a study on newer modalities of treatment is warranted.

The role that human gut microbiota plays in health and disease is receiving considerable attention. Targeting intestinal dysbiosis, a phenomenon found to be intricately linked with the causation of alcoholic hepatitis, could provide insights into novel therapeutic strategies.

Fecal microbiota transplantation is a novel approach that has gained widespread acceptance in in the management of recurrent severe Clostridium difficile infection. It's role is also being studied in other diseases where an association with gut dysbiosis has been found, such as in inflammatory bowel disease and irritable bowel syndrome. The role of FMT has also been studied in liver diseases such as non-alcoholic fatty liver disease (NAFLD), liver cirrhosis and primary sclerosing cholangitis. In this process, a diseased recipient is transferred fecal material containing the microflora of a healthy individual. It limits the colonization of pathogens, inducing colonization resistance, affects microbiota composition in the gut, as well as metabolism in the microbial pathogens. FMT helps alleviate gut dysbiosis and restores gut microbial diversity.

Our aim is to evaluate the role of FMT on short term survival and improvement in scores of prognostic significance (CTP, MELD, MELDNa, mDF) in patients with severe alcoholic hepatitis.

Condition or disease Intervention/treatment Phase
Severe Alcoholic Hepatitis Other: Fecal Microbiota Transplantation Other: Standard of care treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis- Assessment of Impact on Prognosis and Short-term Outcome
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention Arm: Fecal microbiota transplantation
30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.
Other: Fecal Microbiota Transplantation
30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.

Control Arm
Nutritional supplementation, supportive management
Other: Standard of care treatment
Nutritional supplementation, supportive management.

Primary Outcome Measures :
  1. Survival [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Improvement in CTP (Child Turcotte Pugh Score) [ Time Frame: 3 months ]
  2. Improvement in MELD score [ Time Frame: 3 months ]
  3. Improvement in MELDNa score [ Time Frame: 3 months ]
  4. Improvement in CLIF SOFA score [ Time Frame: 3 months ]
  5. Improvement in mDF [ Time Frame: 3 months ]
  6. Changes in inflammatory markers (IL1b, IL6, TNF α) pre and post FMT, [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Severe alcoholic hepatitis will be defined as proposed by the American College of Gastroenterology

    1. Rapid development or worsening of jaundice and liver-related complications with serum total bilirubin more than 3 milligrams per decilitre.
    2. Aspartate aminotransferase and alanine aminotransferase elevated to more than one and half times the upper limit of normal, but less than 400 IU per litre, with AST to ALT ratio over 1.5.
    3. Documentation of persistent heavy alcohol use until 8 weeks before onset of symptoms.
    4. Alcohol Consumption in female over 40 grams per day for at least 6 months and in males over 60 grams per day for at least 6 months.
    5. Maddrey's Discriminant Function Score of more than 32 OR
    6. A patient of alcoholic hepatitis who will present with grade 1 or 2 of hepatic encephalopathy.

Exclusion Criteria:

  1. Intestinal paralysis, lack of bowel sounds, intestinal perforation.
  2. Uncontrolled infections.
  3. Uncontrolled upper gastrointestinal bleeding.
  4. Grade 3,4 hepatic encephalopathy.
  5. Hepatic or extrahepatic malignancy.
  6. Maddrey's Discriminant Function (mDF) >90 or MELD>30.
  7. Autoimmune hepatitis, Wilson's disease, suspected drug induced liver injury.
  8. Patients who are aged >60 years
  9. WBC count <1000 cells/mm3
  10. Pregnancy or nursing.
  11. Human Immunodeficiency Virus (HIV), HBV, HCV infection.
  12. Patient's unwillingness to participate in the study.
  13. Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study.

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 identifier (NCT number): NCT03827772

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Contact: Radha K Dhiman, DM 7087009337

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Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Radha K Dhiman, DM    7087009337   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
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Responsible Party: Radha K Dhiman, Professor and Head, Department of Hepatology, Postgraduate Institute of Medical Education and Research Identifier: NCT03827772    
Other Study ID Numbers: PGIMER Hepatology
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 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, 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