Clostridioides difficile infection
Conditions
Interventions
Normal dosage group:Take healthy human intestinal flora capsules orally, 20 capsules a day, for 3 consecutive days, a total of 60 capsules
High dose group:Take healthy human intestinal flora capsules orally, 40 capsules a day, for 3 consecutive days, a total of 120 Capsules
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects aged 18 years or older, regardless of gender; 2.Patients who have received tumor chemotherapy (including chemoradiotherapy or chemoimmunotherapy) and developed Clostridioides difficile infection (CDI) within =3 episodes of unformed stools per day, with other causes preliminarily excluded, and a positive nucleic acid amplification test (NAAT) for toxigenic C. difficile, or a positive glutamate dehydrogenase (GDH) test combined with a positive test for either C. difficile toxin A or B; 3.With a life expectancy of at least 3 months; 4.Ability to understand and voluntarily provide written informed consent prior to the trial, and willingness and capability to comply with all study requirements as outlined in the protocol; 5.Agreement to use highly effective contraception throughout the trial (within 90 days post-treatment). Female subjects of childbearing potential must have a negative pregnancy test at screening.
Exclusion criteria
Exclusion criteria: 1.History of allergy to the medical technology/intervention involved, or a known allergic constitution (e.g., multiple drug/food/pollen allergies, or history of allergic reactions of unclear etiology), which in the investigator’s judgment precludes safe participation in the study; 2.Presence of clinically significant laboratory abnormalities as determined by the investigator, or any condition causing dysphagia that would impair the ability to swallow the study capsule; 3.The subject has intestinal obstruction; 4.Administration of a live (attenuated) vaccine within 4 weeks prior to screening, or planned receipt of such a vaccine during the trial period; 5.History of substance abuse within the past five years, or use of illicit drugs within 3 months prior to the trial; 6.Concurrent participation in another clinical trial, or having received an investigational intervention in another drug clinical trial within 3 months prior to screening; 7.Any other systemic condition that, in the investigator’s opinion, may compromise the subject’s tolerance to the investigational capsule, or interfere with the assessment of its safety or efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clostridioides difficile testing result;Bristol Stool Form Scale;Gut Microbiota; | — |
Countries
China
Contacts
Public ContactWei-Feng Huang
The First Affiliated Hospital of Xiamen University
Outcome results
None listed