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Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

N

Nanjing Medical University

Status

Enrolling

Conditions

Intestinal Infection
Antibiotic-associated Diarrhea
Clostridioides Difficile Infection

Treatments

Other: rescue fecal microbiota transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT03895593
FMT-CN-190321

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

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Central trial contact

faming zhang, MD,PhD; bota cui, MD,PhD

Data sourced from clinicaltrials.gov

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