MedTrace Logo

Fecal Microbiome Transplantation in Cirrhosis: Trial in Patients With Decompensated Cirrhosis

NCT06533852 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-08-01

No results posted yet for this study

Summary

This is a phase III, multicenter, double-blind, placebo-controlled, randomized clinical trial to evaluate the safety and efficacy of Fecal Microbiota Transplantation (FMT) from healthy subjects to patients with decompensated cirrhosis.

Conditions

  • Decompensated Cirrhosis

Interventions

DRUG

Fecal Microbiome Transplantation (FMT)

Two doses: First dose: 24 capsules of FMT at baseline. Second dose: 24 capsules of FMT at 3 months.

OTHER

FMT Placebo

Two doses: First dose: 24 capsules of FMT placebo at baseline. Second dose: 24 capsules of FMT placebo at 3 months.

Sponsors & Collaborators

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2028-05-31
Completion
2028-05-31

More Related Trials

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 NCT06533852 on ClinicalTrials.gov