Clostridioides difficile infection
Conditions
Interventions
standard dose group:fecal microbiota transplantation(FMT)
high dose group:fecal microbiota transplantation(FMT)
Sponsors
Xiang’an Hospital Affiliated to Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years, any gender. 2.For patients with post-organ transplant diarrhea or antibiotic-associated diarrhea (defined as the onset of loose or watery stools >=3 times per day after recent or ongoing antibiotic use, without other identifiable causes) diagnosed as Clostridioides difficile infection (CDI) according to the Chinese Guidelines for the Diagnosis, Treatment, and Prevention of Clostridioides difficile Infection (2024): The patient is defined as having =3 unformed bowel movements per day, with other causes preliminarily excluded, and meets either of the following laboratory criteria: Positive Clostridioides difficile toxin gene detected by nucleic acid amplification test (NAAT), or Positive glutamate dehydrogenase (GDH) test plus positive toxin A/B test (either toxin A or B). 3.Ability to provide written informed consent and comply with study procedures. 4.Commitment to contraception for 90 days post-treatment (WOCBP: negative pregnancy test at screening).
Exclusion criteria
Exclusion criteria: 1.Allergy to Investigational Product or allergy-prone status (e.g., multiple drug/food/pollen allergies, or idiopathic hypersensitivity), deemed by investigators as ineligible for participation. 2.Patients with clinically significant laboratory abnormalities as judged by the investigator, or those with dysphagia. 3.Patients with intestinal obstruction or other severe gastrointestinal conditions (e.g., life-threatening perforation or hemorrhage) requiring immediate treatment. 4.With severe cardiovascular or cerebrovascular diseases, other serious infections, or uncontrolled systemic diseases. 5.Administration of live/attenuated vaccines within 4 weeks prior to screening or planned during the trial. 6.Drug abuse history within the past 5 years or use of illicit drugs within 3 months prior to screening. 7.Current participation in other interventional trials, or receipt of investigational drugs within 3 months prior to screening. 8.Any other systemic disease (investigator’s judgment) that may compromise IP tolerability or safety/efficacy assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs);Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| CDI recurrence rate;Mean time to CDI recurrence;Changes in gut microbiota structure;Response rate; | — |
Countries
China
Contacts
Public ContactHao Li
Xiang’an Hospital Affiliated to Xiamen University
Outcome results
None listed