Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2026-01-29 @ 12:43 PM
Study NCT ID:
NCT01790061
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2013-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
Study Overview
Official Title:
Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
None
Brief Summary:
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).
Detailed Description:
The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.
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?: