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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05319067
Eligibility Criteria:
Inclusion Criteria:
* The patient must be a member or beneficiary of a health insurance plan
* Patient with no objection to participation in the study from the parent or guardian
* Child with a diversified diet.
o Specific inclusion criteria for group 1 (cases):
* Child with grade 3 or higher vesicoureteral reflux.
* Child on trimethoprim-sulfamethoxazole therapy for at least 5 months.
o Specific inclusion criteria for group 2 (controls):
* Child with uropathy and without long-term trimethoprim-sulfamethoxazole treatment.
o Specific inclusion criteria for group 3 (healthy controls):
* Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment.
Exclusion Criteria:
* Chronic digestive pathology
* Acute gastroenteritis or infectious colitis within last 15 days.
* Curative antibiotic therapy taken less than one month ago.
* Chronic inflammatory bowel disease or other localizations
* Congenital or acquired immune deficiency (current treatment with methotrexate, biotherapies, immunosuppressants)
* Patient participating in a category 1 trial likely to modify the intestinal microbiota.
* Patient in an exclusion period determined by another study.
* Patient under court protection, guardianship or curatorship.
* Patient for whom it is impossible to give informed information to person with parental authority.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT05319067
Study Brief:
Protocol Section:
NCT05319067