Trials / Recruiting
RecruitingNCT03895593
Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections
Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- The Second Hospital of Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | rescue fecal microbiota transplantation | Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract. The delivering ways for FMT include but are not limited to gastroscopy, colonoscopy, edema, nasogastric tube, transendoscopic enteral tube, and etc. |
Timeline
- Start date
- 2015-09-25
- Primary completion
- 2024-05-01
- Completion
- 2029-05-01
- First posted
- 2019-03-29
- Last updated
- 2024-02-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03895593. Inclusion in this directory is not an endorsement.