Washing and transplanting gut bacteria to treat Clostridioides Difficile Infection

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

This study is testing if washing and transplanting gut bacteria can help people with Clostridioides Difficile Infection feel better and recover.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 3 Years to 100 Years
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06106698 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and efficacy of washed microbiota transplantation (WMT) in patients suffering from Clostridioides Difficile Infection (CDI). A minimum of 12 participants who meet specific inclusion criteria will be enrolled, and their demographic data, intestinal symptoms, medication usage, and clinical outcomes will be collected. Following the WMT treatment, participants will be monitored for at least four weeks to assess safety and effectiveness, with additional follow-up for those experiencing no response or recurrence.

Who should consider this trial

Good fit: Ideal candidates for this study are male or non-pregnant, non-lactating females diagnosed with Clostridioides Difficile Infection who have experienced diarrhea episodes.

Not a fit: Patients who do not meet the diagnostic criteria for Clostridioides Difficile Infection or have contraindications for microbiota transplantation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients suffering from recurrent Clostridioides Difficile Infection.

How similar studies have performed: Previous studies on microbiota transplantation have shown promising results in treating Clostridioides Difficile Infection, indicating that this approach has potential based on existing evidence.

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.

Where this trial is running

Nanjing, Jiangsu

• The second affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Faming Zhang — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, PhD

Conditions Clostridioides Difficile Infection; washed microbiota transplantation; Intestinal infection; Antibiotic-associated Diarrhea