Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-03-03 @ 11:15 AM
Study NCT ID:
NCT03014505
Status:
UNKNOWN
Last Update Posted:
2017-01-09
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fecal Microbiota Transplantation for Decompensated Cirrhosis
Sponsor:
First Affiliated Hospital of Chengdu Medical College
Organization:
Study Overview
Official Title:
Fecal Microbiota Transplantation Versus Standard Therapy in Decompensated Cirrhosis: A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMTDC
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: