Washed Microbiota Transplantation for Clostridioides Difficile Infection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-100
SponsorThe Second Hospital of Nanjing Medical University

About this trial

This is a real-world study to explore the safety and the efficacy of washed microbiota transplantation (WMT) for patients with Clostridioides Difficile Infection (CDI).

Eligibility criteria

Qualifiers

At the time of informed consent, male or non-pregnant or non-lactating female.

Medical records confirming CDI prior to screening (laboratory tests are positive for Clostridium difficile or its toxin): Clostridium difficile toxin test is positive (determined by EIisa test), or colonoscopy indicates pseudomembranous enteritis; Or Glutamate dehydrogenase positive, toxin negative, there are obvious causes and diarrhea.

CDI-related diarrhea episodes, i.e., defecation ≥3 times/day for at least two consecutive days with unformed stools (Bristol score 6-7).

The subject or his/her legal representative gives informed consent, fully understands the purpose of the study, is able to communicate effectively with the investigator, and comprehends and complies with the requirements set forth in the study.

Disqualifiers

Subjects with immune deficiencies (such as HIV infection, or neutrophils <0.5×109/L in absolute value, or lymphocytes <0.5×109/L, etc.), or on immunosuppressants, or on medium to high doses of steroid hormones (≥20g/d of prednisone or equal doses of steroid hormones).

There is rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis assessed by the investigator and colonic transendoscopic enteral tubing cannot be performed.

Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.

Have had major abdominal surgery (other than laparoscopic gallbladder or appendectomy), previous partial or total colectomy, previous partial small intestinal resection, or previous gastroduodenal surgery within 6 months prior to screening.

Trial design

Treatments tested in this trial

  • WMT

Treatment groups

No treatment groups listed