This is a prospective, open-label, single-arm study to explore the safety and the efficacy of CMTS0929 for patients with Clostridioides difficile infection (CDI).
At the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females.
At the time of screening, meet the diagnostic criteria for Clostridioides difficile infection: a)There is a medical record proving a confirmed CDI before screening (laboratory tests show positive results for Clostridioides difficile or its toxins): positive results in Clostridioides difficile toxin detection (determined by EIAs) or colonoscopy indicating pseudomembranous colitis; or positive GDH with negative toxin results, along with obvious predisposing factors and diarrhea. b)Have an episode of CDI - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (Bristol Stool Form Scale score of 6 - 7).
The subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study.
Subjects with immunodeficiency (such as HIV infection, or absolute neutrophil count < 0.5×10⁹/L, or total lymphocyte count < 0.5×10⁹/L, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g/d prednisone or equivalent steroid hormones).
Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET.
Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile.
Within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery.