Efficacy and Safety of Fecal Microbiota Transplant for Secondary Prophylaxis of Hepatic Encephalopathy

NCT05229289 | Unknown

• 1 other identifier: ILBS- Cirrhosis-40
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Despite standard of care, the recurrence of hepatic encephalopathy remains the primary cause for readmissions in individuals with cirrhosis. Patients with cirrhosis have disturbed gut microbiota, which is exacerbated by repeated antibiotic usage. FMT is a promising therapy to restore a healthy microbiota. FMT causes change in composition of gut microbiota which will lead to increase in commensal bacterial diversity which will increase colonization resistance to pathogenic bacteria and thereby decrease the bacterial overgrowth. Healthy bacteria also increase the SCFA production in colon with is and nutrient for endothelial cells and thereby protect the endothelial integrity and decreases bacterial translocation and endotoxemia. Current standard of care mainly focuses on the treatment of precipitating factors of the HE. The goal of our open-label, randomised clinical trial is to evaluate the safety, efficacy of addition of FMT to SOC in preventing subsequent episodes of hepatic encephalopathy.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients developing an episode of hepatic encephalopathy within 6 months

  6 months

Secondary Outcomes (26)

• Proportion of patients developing adverse event related to FMT within 6 months

  6 months

• Number of Participants with Transplant free survival at day 28

  Day 28

• Number of Participants with Transplant free survival at day 90

  Day 90

• Number of Participants with Transplant free survival at day 180

  Day 180

• Change in Ammonia level at day baseline, 28 days

  28 days

Study Arms (2)

FMT along with SMT

EXPERIMENTAL

FMT + Standard medical therapy (SMT): Lactulose (Titrated to 2-3 soft bowel movements per day) Oral LOLA can be used as an alternative or additional agent to treat patients non-responsive to conventional therapy Oral BCAAs can be used as an alternative or additional agent to treat patients non-responsive to conventional therapy Diet Daily energy intakes of 35-40 kcal/kg ideal body weight Daily protein intake 1.2-1.5 g/kg/day Small meals or liquid nutritional supplements evenly distributed throughout the day Oral BCAA supplementation in patient's intolerant of dietary protein (to allow recommended nitrogen intake to be achieved and maintained)

Other: Standard Medical Treatment; Other: Fecal Microbiota Transplant

Standard Medical Treatment

ACTIVE COMPARATOR

Standard medical therapy (SMT): Lactulose (Titrated to 2-3 soft bowel movements per day) Oral LOLA can be used as an alternative or additional agent to treat patients non-responsive to conventional therapy Oral BCAAs can be used as an alternative or additional agent to treat patients non-responsive to conventional therapy Diet Daily energy intakes of 35-40 kcal/kg ideal body weight Daily protein intake 1.2-1.5 g/kg/day Small meals or liquid nutritional supplements evenly distributed throughout the day Oral BCAA supplementation in patient's intolerant of dietary protein (to allow recommended nitrogen intake to be achieved and maintained)

Other: Standard Medical Treatment

Interventions

Standard Medical Treatment OTHER

Standard medical therapy (SMT): Lactulose (Titrated to 2-3 soft bowel movements per day) Oral LOLA can be used as an alternative or additional agent to treat patients non-responsive to conventional therapy Oral BCAAs can be used as an alternative or additional agent to treat patients non-responsive to conventional therapy Diet Daily energy intakes of 35-40 kcal/kg ideal body weight Daily protein intake 1.2-1.5 g/kg/day Small meals or liquid nutritional supplements evenly distributed throughout the day Oral BCAA supplementation in patient's intolerant of dietary protein (to allow recommended nitrogen intake to be achieved and maintained)

FMT along with SMT; Standard Medical Treatment

Fecal Microbiota Transplant OTHER

Fecal Microbiota Transplant

FMT along with SMT

Eligibility Criteria

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

You may qualify if:

• \- All cirrhotic patients between 18 years to 70 years, who have recovered within 7 days from hepatic encephalopathy after hospitalization

You may not qualify if:

• Patient having hepatic encephalopathy after obvious precipitants (eg. diuretics, dehydration)
• Patients on immunosuppressive medications
• Active Infection (documented blood culture positive, Imaging diagnosis or SIRS\>=1)
• AKI (Defined as per KIDGO guidelines)
• GI Bleed (In past 14 days)
• Hepatocellular carcinoma
• Patient with portosystemic shunt with size \>10mm
• Patients with previous TIPS or shunt surgery
• Patients with significant comorbid illness such as heart, respiratory, or renal failure
• Any neurologic diseases such as Alzheimer's disease, Parkinson's disease
• Non hepatic metabolic encephalopathies
• Not willing for the study

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

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Dr Tushar Madhav Madke, MD

CONTACT

01146300000; drtusharmadke@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: December 24, 2021
• First Posted: February 8, 2022
• Study Start: January 31, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 8, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)