Status:
RECRUITING
Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Vesicoureteral Reflux 3
Eligibility:
All Genders
1-3 years
Brief Summary
Urinary tract infections are very common in pediatrics. Urinary antibiotic prophylaxis is commonly used in children with malformative uropathies. Long-term, low-dose antibiotic prophylaxis with trimet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05319067
Start Date
May 1 2017
End Date
November 1 2026
Last Update
November 17 2025
Active Locations (2)
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1
CHU de Montpellier
Montpellier, France
2
CHU de Nîmes
Nîmes, France