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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fecal Microbiota Transplantation in Decompensated Cirrhosis

NCT04842539

Liver Cirrhosis

COMPLETED NA

Intra-Hepatic Microbiota in Alcoholic Hepatitis

NCT06307964

Cirrhosis Alcoholic Liver Disease Alcoholic Hepatitis

RECRUITING

GCSF in Alcoholic Hepatitis

NCT03703674

Alcoholic Hepatitis

UNKNOWN PHASE4

Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function

NCT06355726

Alcoholic Hepatitis

RECRUITING NA

Effect of Transjugular Intrahepatic Portosystemic Shunt on Gut Microbiota in Cirrhotic Patients

NCT02427906

Cirrhosis Acquired Portal-systemic Shunt Due to Cirrhosis Hepatic Encephalopathy

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Alcoholic Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm: Fecal microbiota transplantation

30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.

Group Type EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type OTHER

30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.

Control Arm

Nutritional supplementation, supportive management

Group Type OTHER

Standard of care treatment

Intervention Type OTHER

Nutritional supplementation, supportive management.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fecal Microbiota Transplantation

30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.

Intervention Type OTHER

Standard of care treatment

Nutritional supplementation, supportive management.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No