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Starting soon Early Phase 1

CMTS0929 for Clostridioides Difficile Infection

NCT06836427 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-02-20
Last updated
2025-02-20

Condition(s) studied

Clostridioides Difficile Infection

Investigational drug(s) / intervention(s)

CMTS0929 →

CMTS0929: CMTS0929 is defined as suspension from washed microbiota.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to enter the study: 1. 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. 2. 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). 3. 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. Exclusion Criteria: Subjects meeting any of the following exclusion criteria must be excluded from the study: 1. 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). 2. Subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo cTET. 3. Before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to Clostridioides difficile. 4. 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. 5. At the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment. 6. As judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.

Primary outcome measure(s)

  • The safety of CMTS0929 — Four-week
    The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0: The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.)

Trial sites (1)

FacilityCityRegionStatus
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06836427 on ClinicalTrials.gov ↗ ← All trials in China