The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection

Tongji University

Status: Completed

Conditions: Clostridium Difficile Infection; Fecal Microbiota Transplantation

Treatments: Procedure: Fecal microbiota transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05703477

FMTCDI

Details and patient eligibility

About

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the treatment of various gastrointestinal diseases, including but not limit in CDI. In this study, we focused on the demonstration of FMT action mechanism in CDI treatment.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged over 18 years old;
2. positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase;
3. can tolerate nasojejunal tube and complete full course of FMT treatment;
4. the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion criteria

1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

FMT Responder

Experimental group

Treatment:

Procedure: Fecal microbiota transplantation

FMT non-Responder

Experimental group

Treatment:

Procedure: Fecal microbiota transplantation