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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Apr 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the gut bacteria (microbiota) in young children aged 1 to 3 years who have a condition called grade 3 or higher vesicoureteral reflux and are taking a long-term antibiotic called trimethoprim-sulfamethoxazole to prevent urinary tract infections. The researchers want to understand how prolonged use of this antibiotic affects the diversity of gut bacteria in these children compared to those who do not take the antibiotic and healthy children without any urinary issues.

To be eligible for the trial, children must be part of a health insurance plan, have a varied diet, and meet specific criteria based on their health status. For example, children in the first group must have grade 3 or higher vesicoureteral reflux and have been on the antibiotic for at least five months. Participants can expect to provide samples for analysis, and this study will help researchers learn more about how antibiotics affect gut health in young children. It's important to know that children with certain digestive or immune conditions will not be able to participate in the study.

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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.