Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

Recruiting

• Conditions: Antibiotic-associated Diarrhea; Intestinal Infection; Clostridioides Difficile Infection

• Registration Number: NCT03895593
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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 Timeline

• Study Start: 2015-09-25
• Status Verified: 2019-03
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-05-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 will be included.

Exclusion Criteria

Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival outcome	4 weeks	The survival outcome refers to the 4-week survival post-FMT.
abdominal symptom outcomes	1 week	Definitions used to classify response, nonresponse and exacerbation for the abdominal symptom outcomes are based on the physicians' holistic evaluation of patients' abdominal symptoms.
clinical cure of clostridioides difficile infection	8 weeks	clinical resolution (absence of diarrhea, or marked reduction in stool frequency), or a negative clostridioides difficile (CD) test, without the need for further anti-clostridioides difficile infection therapy

Secondary Outcome Measures

Name	Time	Method
adverse events	12 weeks	Unfavorable signs, symptoms, or major changes from pre-FMT laboratory test results.

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China