Status:
RECRUITING
Washed Microbiota Transplantation for Clostridioides Difficile Infection
Lead Sponsor:
The Second Hospital of Nanjing Medical University
Conditions:
Clostridioides Difficile Infection
Eligibility:
All Genders
3-100 years
Brief 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）.
Detailed Description
At least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, intestinal symptoms, medicine treat...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following inclusion criteria to enter the study:
- 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
- Subjects meeting any of the following exclusion criteria must be excluded from the study:
- 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.
Key Trial Info
Start Date :
July 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06106698
Start Date
July 22 2023
End Date
December 1 2029
Last Update
October 30 2023
Active Locations (1)
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1
The second affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011