Clostridioides difficile infection
Conditions
Interventions
Low-dose group:Fecal microbiota transplantation(FMT)
Medium-dose group:Fecal microbiota transplantation(FMT)
High-dose group:Fecal microbiota transplantation(FMT)
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years, regardless of gender; 2.Diagnosed with Clostridioides difficile infection (CDI) according to the Chinese Guidelines for the Diagnosis, Treatment, and Prevention of Clostridioides difficile Infection (2024), including both initial and recurrent cases: The patient is defined as having =3 unformed bowel movements per day after initially ruling out other causes, with a positive nucleic acid amplification test (NAAT) for C. difficile toxin genes, or a positive glutamate dehydrogenase (GDH) test along with a positive result for either toxin A or B in the C. difficile toxin A/B assay. 3.Capable of understanding and voluntarily signing the informed consent form before the trial, and able to complete the study in accordance with the trial protocol requirements; 4.Agrees to use effective contraception throughout the entire trial period (within 90 days after treatment), and women of childbearing potential are required to have a negative pregnancy test during the screening period;
Exclusion criteria
Exclusion criteria: 1.History of allergy to the medical technology, or allergic constitution (e.g., allergy to multiple drugs, foods, or pollen, or prone to allergic reactions without identifiable cause), as deemed by the investigator to be unsuitable for participation. 2.Laboratory test results judged by the investigator to be abnormal and clinically significant, or presence of dysphagia; 3.Subject has intestinal obstruction. 4.Presence of the following hematological diseases confirmed during the screening period: thrombocytopenia (defined as platelets < 90,000/mm³ within 30 days prior to screening), anemia (defined as hemoglobin < 10 g/dL or transfusion dependence within 30 days prior to screening), neutropenia (defined as absolute neutrophil count < 1,000/mm³ within 30 days prior to screening). 5.Administration of a live (attenuated) vaccine within 4 weeks prior to screening, or planned vaccination during the trial. 6.History of drug abuse within the past five years or use of narcotics within 3 months prior to the trial. 7.Current participation in another clinical trial, or receipt of investigational drug intervention in another clinical trial within 3 months. 8.Presence of any other systemic disease that, in the investigator's judgment, may affect tolerance to the investigational capsules or the evaluation of their safety and efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean time to CDI recurrence;Changes in gut microbiota structure;Recurrence rate of CDI;Response rate for intervention; | — |
Countries
China
Contacts
Public ContactRongfeng Huang
Fujian Medical University Union Hospital
Outcome results
None listed