Washed Microbiota Transplantation for Clostridioides Difficile Infection

Launched by THE SECOND HOSPITAL OF NANJING MEDICAL UNIVERSITY · Oct 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called washed microbiota transplantation (WMT) for people who have Clostridioides Difficile Infection (CDI), which is a serious infection that can cause severe diarrhea and other intestinal problems. The goal of the study is to see how safe and effective this treatment is in helping patients recover from CDI. The trial is currently looking for participants, and anyone between the ages of about 3 to 100 years old can join as long as they meet certain health criteria.

To be eligible, participants must have a confirmed diagnosis of CDI, which means they have tested positive for the infection and are experiencing symptoms like diarrhea that occurs three or more times a day. Participants should also be able to communicate well with the study team and understand the study's purpose. However, people with certain health issues, like weakened immune systems or recent major surgeries, cannot participate. If you decide to take part, you'll receive the WMT treatment and be monitored closely to see how well it works for you. Your safety and understanding of the process are the top priorities throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all of the following inclusion criteria to enter the study:
• • 1. At the time of informed consent, male or non-pregnant or non-lactating female.
• 2. The diagnostic criteria for C. difficile infection are met during screening:
• • 1. 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.
• • 2. CDI-related diarrhea episodes, i.e., defecation ≥3 times/day for at least two consecutive days with unformed stools (Bristol score 6-7).
• • 3. 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 Criteria:
• Subjects meeting any of the following exclusion criteria must be excluded from the study:
• • 1. 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).
• • 2. 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.
• • 3. Confirmed or clinically suspected infection with pathogenic microorganisms other than Clostridium difficile prior to screening.
• • 4. 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.
• • 5. At the time of screening, the subject or his/her legal representative refuses to take effective contraception within 3 months after the last treatment.
• • 6. 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.