Examining gut microbiota diversity in young children on long-term antibiotic prophylaxis for urinary reflux
Official title: 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
Run by Centre Hospitalier Universitaire de Nīmes · NCT05319067 · Data updated 2026-11-12
This study looks at how long-term antibiotic use affects the gut bacteria in young children with urinary reflux compared to other children who don't take antibiotics.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 3 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Status | Recruiting |
| Started | December 2, 2022 |
| Main results expected | December 1, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT05319067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 1-3 years with grade 3 or higher vesicoureteral reflux who have been on trimethoprim-sulfamethoxazole therapy for at least 5 months.
✕Probably not a fit
Patients with chronic digestive pathology or those who have had recent acute gastroenteritis or curative antibiotic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the gut microbiota diversity in children aged 1-3 years who are receiving prolonged antibiotic prophylaxis for grade 3 or higher vesicoureteral reflux. It compares these children to two age-matched control groups: those with uropathy not on long-term antibiotics and healthy children without uropathy. The study involves stool sampling to analyze the microbiota composition and its potential implications for antibiotic resistance and immune modulation. The goal is to understand how long-term antibiotic use affects gut microbiota diversity in this pediatric population.
Why it matters
Potential benefit: If successful, this study could provide insights into the impact of prolonged antibiotic use on gut health and inform better management strategies for children with urinary tract infections.
How similar studies have gone: Other studies have indicated that long-term antibiotic use can significantly alter gut microbiota, suggesting that this approach may yield valuable insights.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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CHU de Montpellier
Montpellier, France Recruiting -
CHU de Nîmes
Nîmes, France Recruiting
Study contacts
- Principal investigator: Anne Filleron — CHU de Nimes
- Study coordinator: Anne Filleron
- Email: anne.filleron@chu-nimes.fr
- Phone: 04.66.68.32.86
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.