Clostridioides difficile Infection
Conditions
Interventions
Standard dose group:Standard dose fecal microbiota transplantation(FMT)
High dose group:High dose fecal microbiota transplantation(FMT)
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, regardless of gender; 2.Patients diagnosed with Clostridioides difficile infection (CDI) according to the Chinese Guidelines for the Diagnosis, Treatment, and Prevention of Clostridioides difficile Infection (2024). Definition of CDI: >=3 unformed bowel movements per day, with other causes preliminarily excluded, and positive results for: Nucleic acid amplification test (NAAT) or glutamate dehydrogenase (GDH) for C. difficile, and Toxin A/B (either toxin A or B positive). 3.Ability to understand and voluntarily sign the informed consent form (ICF) before the trial, and willingness to comply with the study protocol; 4.Agreement to use effective contraception throughout the trial (within 90 days post-treatment). For women of childbearing potential (WOCBP): Negative pregnancy test at screening.
Exclusion criteria
Exclusion criteria: 1.History of allergy to medical interventions or allergic constitution (e.g., allergies to multiple drugs, foods, or pollen, or unexplained allergic reactions), as determined by the investigator to preclude participation; 2.Clinically significant abnormal laboratory findings (investigator’s judgment), dysphagia, or a history of conditions affecting drug absorption/excretion within the 6 months prior to screening; 3.Presence of intestinal obstruction; 4.Hematologic disorders identified during screening, including: Thrombocytopenia (platelet count <90,000/mm^3 within 30 days before screening), Anemia (hemoglobin <10 g/dL within 30 days before screening or transfusion dependence), Neutropenia (absolute neutrophil count <1,000/mm^3 within 30 days before screening); 5.Administration of live (attenuated) vaccines within 4 weeks before screening or planned during the trial; 6.History of drug abuse within the past 5 years or use of illicit drugs within 3 months before screening; 7.Current participation in another clinical trial or receipt of investigational drugs within 3 months prior to screening; 8.Any other systemic condition (investigator’s judgment) that may affect tolerability of the study capsule or compromise safety/efficacy evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Incidence of adverse events (AEs) and serious adverse events (SAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean time to CDI recurrence;Changes in gut microbiota structure;Response rate;CDI recurrence rate; | — |
Countries
China
Contacts
Public ContactMengshi Chen
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed