NCT03895593

Rescue Fecal Microbiota Transplantation for National Refractory Intestinal Infections

Recruiting now Last updated 29 February 2024

What this trial tests

trial testing rescue fecal microbiota transplantation in Intestinal Infection in 100 participants. Currently enrolling.

Timeline

25 September 2015

Primary endpoint
1 May 2024

1 May 2029

Quick facts

Lead sponsor	The Second Hospital of Nanjing Medical University
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	100
Start date	25 September 2015
Primary completion	1 May 2024
Estimated completion	1 May 2029
Sites	1 location across China

Drugs / interventions tested

• rescue fecal microbiota transplantation

Conditions studied

• Intestinal Infection — all drugs for Intestinal Infection →
• Clostridioides Difficile Infection — all drugs for Clostridioides Difficile Infection →
• Antibiotic-associated Diarrhea — all drugs for Antibiotic-associated Diarrhea →

Sponsor

The Second Hospital of Nanjing Medical University

Who can join

Eligibility, any sex, with Intestinal Infection or Clostridioides Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients.
   Dai M, Liu Y, Chen W, Buch H, et al · · 2019 · cited 50× · PMID 31639033 · DOI 10.1186/s13054-019-2604-5
2. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery.
   Lu G, Wang W, Li P, Wen Q, et al · · 2022 · cited 39× · PMID 35576458 · DOI 10.1111/1751-7915.14074
3. Washed microbiota transplantation for Clostridioides difficile infection: A national multicenter real-world study.
   Wu X, Ai RJ, Xu J, Wen Q, et al · · 2023 · cited 15× · PMID 37681235 · DOI 10.1111/1751-2980.13227
4. Frontiers in antibiotic alternatives for <i>Clostridioides difficile</i> infection.
   Phanchana M, Harnvoravongchai P, Wongkuna S, Phetruen T, et al · · 2021 · cited 12× · PMID 34876784 · DOI 10.3748/wjg.v27.i42.7210
5. Washed Microbiota Transplantation as a Rescue Therapy for Refractory Unidentified Pathogen Intestinal Infections: Findings From a National Multi-Centre, Real-World Study.
   Zhang S, Li P, Dai M, Wu X, et al · · 2026 · PMID 41873680 · DOI 10.1111/1751-7915.70335