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

NCT05229289 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-02-08

No results posted yet for this study

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

Interventions

OTHER

Standard Medical Treatment

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

Fecal Microbiota Transplant

Fecal Microbiota Transplant

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229289 on ClinicalTrials.gov