RecruitingNCT06106698

Washed Microbiota Transplantation for Clostridioides Difficile Infection

Washed Microbiota Transplantation for Clostridioides Difficile Infection: a Real World Research

Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

100 participants

Start Date

Jul 22, 2023

Study Type

OBSERVATIONAL

Conditions

Clostridioides Difficile Infection

Summary

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

Min Age: 3 YearsMax Age: 100 Years

Inclusion Criteria5

At the time of informed consent, male or non-pregnant or non-lactating female.
The diagnostic criteria for C. difficile infection are met during screening:
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.

Exclusion Criteria6

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.
At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
According to the judgment of the investigator, the subjects are not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subjects.

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Interventions

OTHERWMT

Washed microbiota transplantation refers to the infusion of washed microbiota from healthy donor into patients' gastrointestinal tract. Participants will receive one dose of WMT for CDI. During follow-up, those who have non-response or CDI recurrence within 4-week post-WMT will receive rescue WMT.