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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT03053505
Eligibility Criteria:
Inclusion Criteria:
* Group "R":- recurrent CDI;- positive stool toxin test within 72 hours before enrolment
* Group "F":- first (initial) episode of CDI;- enrolled patient falls in at least one of the following categories:high risk of recurrence or high risk of developing severe CDI or severe or life-threatening CDI;- patient requires hospitalization or CDI occurs during a hospital stay;- persisting symptoms despite least 72 hours of adequate antibiotic treatment;-positive stool CD toxin test obtained within 72 hours before screening;- in all cases, primary consideration must be given to the severity and pace of the patient's CDI when deciding whether early use of FMT is appropriate to prevent further clinical deterioration.
Exclusion Criteria:
* absence of either patient's or its legally authorized representative's informed consent
* inability or unwillingness to comply with protocol requirements
* severe co-morbidities, terminal underlying disease with a life expectancy of less than 90 days
* pregnancy or breastfeeding
* active gastroenteritis caused by microorganisms other than CD
* underlying chronic gastrointestinal disease that causes diarrhoea such as autonomic diabetic neuropathy, short bowel syndrome, faecal incontinence, active inflammatory bowel disease
* alimentary or over-the-counter drog allergy with previous anaphylactic reaction
* absolute contraindication to FMT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03053505
Study Brief:
Protocol Section:
NCT03053505