Washing and transplanting gut bacteria to treat Clostridioides Difficile Infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: fzhang@njmu.edu.cn
• Phone: 086-025-58509883

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Diet and counseling to see how meals affect gut health after CDI

  We’re testing whether different meal plans and health counseling can influence the gut microbiome and reduce chances of CDI coming back in adults who are being treated for CDI.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07613645

• Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

  This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.

  Recruiting Phase 1 University of Alberta · Calgary, Alberta and 1 other locations · NCT07401680

• How antibiotics versus fecal transplants affect recovery from C. difficile infection

  This project will see how antibiotics and fecal microbiota transplant (FMT) affect adults with C. difficile infection by tracking recovery and biological changes over time.

  Recruiting Umeå University · Umeå · NCT07374094

• Preventing recurrent C. difficile infection with the AZD5148 antibody

  This will try a single dose of the antibody AZD5148 versus placebo to see if it prevents repeat C. difficile infections in adults being treated for a current infection.

  Recruiting at 95 sites Phase 2 AstraZeneca · Phoenix, Arizona and 116 other locations · NCT07285213

• Preventing C. difficile recurrence with short-course oral vancomycin during later antibiotics

  This trial tests whether taking short-course oral vancomycin while you need systemic antibiotics can prevent a recurrence of C. difficile in adults recently treated for CDI.

  Recruiting Phase 2/3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT06979609

• UDCA added to standard therapy to prevent C. diff recurrence

  This study tests whether taking ursodeoxycholic acid alongside standard antibiotics can reduce recurrence of C. difficile colitis in adults at risk.

  Recruiting Early Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT06884748

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.