NCT03014505

Fecal Microbiota Transplantation for Decompensated Cirrhosis

Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: First Affiliated Hospital of Chengdu Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Imbalance of gut bacteria is suspected to play a key role driving the progression of cirrhosis and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation is an effective and safe treatment for decompensated cirrhosis.

Detailed description

Two groups of inpatients with decompensated cirrhosis will be randomized using random sequence generator into experimental and control groups. Two groups will given traditional treatments and experimental group will added treatment with fecal microbiota transplantation via endoscope and/or cenema.The liver function parameters, adverse events complication, systemic inflammatory markers, Intestinal mucosa structure, permeability changes in the intestinal mucosal barrier, Microbiota composition will be assessed and thereafter at 1 month and 3 months \& subjects will be clinically assessed for improvement or worsening.

Conditions

• Decompensated Cirrhosis
• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	FMT	Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
OTHER	traditional treatments	traditional treatments for Decompensated Cirrhosis in part 2

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-03-01
• Completion: 2018-07-01
• First posted: 2017-01-09
• Last updated: 2017-01-09

Locations

1 site across 1 country: China