Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT03895593
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
Study Overview
Official Title:
Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry
Status:
RECRUITING
Status Verified Date:
2019-03
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:
A national data registry of patients receiving the rescue fecal microbiota transplantation for the refractory intestinal infections from the China Microbiota Transplantation System was designed to assess the short-term and long-term safety and efficacy.
Detailed Description:
This registry will enroll national patients with refractory intestinal infections (including clostridioides difficile infection, other infections with known or unknown pathogens) receiving rescue fecal microbiota transplantation (FMT) from the the China Microbiota Transplantation System. The improved methodology of FMT based on the automatic washing process and the related delivering consideration was named as washed microbiota transplantation (WMT) by the consensus statement from the FMT-standardization study group in 2019.12. Data of demographic characteristics, symptoms of intestinal infections, previous medicine treatment and clinical outcomes will be collected retrospectively abstracted from the electronic medical records or prospective follow-up. All the patients will be followed up for at least 12 weeks post-FMT. Information on follow-up will be designed to assess the short-term and long-term adverse events.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: