Fecal Microbiota Therapy in Steroid Ineligible Alcoholic Hepatitis

NCT05285592 | Unknown

• 1 other identifier: ILBS-Alcoholic Hepatitis-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. Since gut dysbiosis, leaky gut, and products of the gut microbiome reaching the liver are the main culprits in the development of alcoholic hepatitis, targeting qualitative and quantitative changes in the gut microbiome remains an important strategy in developing new therapies for alcoholic hepatitis. Among others, the modulation of gut microbiota by fecal microbiota transplantation (FMT) has recently been conceptualized and evaluated as a potential therapeutic strategy in both preclinical and clinical studies.

Conditions

Alcoholic Hepatitis

Outcome Measures

Primary Outcomes (2)

• Mortality at 3 months

  3 months

• Liver transplant free survival

  3 months

Secondary Outcomes (4)

• End of study period

  6 months

• Mortality

  1 month

• Post therapy assessment in the form of clinical improvement (hepatic encephalopathy, ascites , improvement in jaundice)(both ascites and HE if present)

  6 months

• Frequency of decompensation events on follow up period

  6 months

Study Arms (2)

Fecal Transplantation

EXPERIMENTAL

1. Donors will be supplied clean, sealable containers for collection and transport of stool. Containers will be labeled with the name, UHID and date/time of stool collection. 2. Collected stool will be immediately transferred to the laboratory facility for processing and used within 6 hours collection 3. Stool sample from Healthy donor will be processed 4. Patient preparation 5. Patient was kept NPO for 4 hours prior to stool instillation 6. Iv antibiotics were continued as per treating doctor in the event of sepsis 7. The patient was allowed to consume the prescribed diet 2 hours after the procedure instillation 8. Methods of FMT infusion. 9. Seven doses (30gm one dose) of FMT will be given via jejunal port of NJ/NG tube

Other: Fecal Transplantation

Standard Medical Treatment

ACTIVE COMPARATOR

Standard Medical Treatment

Drug: Standard Medical Treatment

Interventions

Fecal Transplantation OTHER

Fecal Transplantation

Fecal Transplantation

Standard Medical Treatment DRUG

Standard Medical Treatment

Standard Medical Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Steroid ineligible severe alcoholic hepatitis as per definition
• Informed consent
• Age 18 - 70 years
• Liver biopsy -if Feasible
• Model for End-Stage Liver Disease (MELD) ≥ 20 and Maddrey DF ≥ 32

You may not qualify if:

• UGI Bleed within last one month
• More then 3 organ failure requiring support
• Mechanically ventilated patient , (patients requiring ICU/ HDU care) (On inotropic support)
• Uncontrolled sepsis, DIC
• Gut paralysis
• Active hepatic or extra hepatic malignancy
• Renal failure creatinine \> 2.5
• DF\>120
• MELD \>35
• Prior SBP/active SBP
• Intestinal conditions like IBD, SIBO
• Donor evaluation The subjects will be screened for
• Routine laboratory tests (CBC; LFT; KFT; PT; INR)
• Fasting blood sugar
• Lipid profile

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Dr Rahul Khajuria, MD

CONTACT

01146300000; dr.rahulkhajuria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 20, 2022

Record last verified: 2022-03

Locations

IN (1)