Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT03796650
Eligibility Criteria:
Inclusion Criteria:
* Patients, ≥18 years with primary C. difficile infection, defined by the following three criteria:
1. Diarrhea as defined by the WHO (≥3 loose stools per day), and
2. Positive stool test for toxin producing C. difficile, and
3. No evidence of previous C. difficile infection during 365 days before enrolment.
* Written informed consent
Exclusion Criteria:
* Known presence of other stool pathogens known to cause diarrhea.
* Ongoing antibiotic treatment for other infections that cannot be stopped before study treatment administration.
* Inflammatory bowel disease or microscopic colitis.
* \< 3 months life expectancy.
* Serious immunodeficiency, defined as one of the following:
* Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of \< 500/μL.
* Active severe immunocompromising disease.
* Inability to comply with protocol requirements.
* Need of intensive care.
* Known irritable bowel syndrome, diarrheal type.
* Pregnancy or nursing.
* Known or suspected toxic megacolon or ileus.
* Total or subtotal colectomy, ileostomy or colonostomy.
* Contraindications for rectal catheter insertion
* Known hypersensitivity or other contraindications to vancomycin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03796650
Study Brief:
Protocol Section:
NCT03796650