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

NCT05319067 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Universitaire de Nīmes

Phase

Observational

Started

2022-12-02

Last updated

2026-04-15

Condition(s) studied

Vesicoureteral Reflux 3

Investigational drug(s) / intervention(s)

Stool sampling

Stool sampling: Stool sample taken at home 24 hours before hospital visit

Study 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 trimethoprim-sulfamethoxazole has been associated with a decrease in the number of urinary tract infections in susceptible children, but not systematically with a decrease in the risk of renal scarring (depending of uropathy stage).

Long-term antibiotic prophylaxis has implications for the acquisition of antibiotic resistance. A child receiving antibiotic prophylaxis for urinary tract infection is around 6 times more likely to develop a multidrug-resistant infection. In the general population, the microbiota of children treated with curative antibiotics is less diverse in terms of species and strains. In addition, short-term compositional changes are observed between consecutive samples of children treated with antibiotics.

The gut microbiota modulates the immune system, in particular via metabolites (SCFA, polysaccharide A) produced by bacteria that modify the expansion and function of regulatory T-cells. The disturbances of the intestinal microbiota play a role in the medium and long term on the acquisition of pathologies, such as atopy.

The study authors wish to describe the intestinal microbiota of children with vesico-ureteral reflux treated long-term with trimethoprim-sulfamethoxazole and compared it those not receiving antibiotic prophylaxis and to healthy children.

Eligibility

Sex

ALL

Min age

1 Year

Max age

3 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

α-diversity of the gut microbiota between groups — Day 0
N index of a stool sample measured by the Shannon index (H\^') which incorporates the total number of different Operational Taxonomic Units and the relative proportions of these Operational Taxonomic Units.

Trial sites (2)

Facility	City	Region	Status
CHU de Montpellier	Montpellier	France	Recruiting
CHU de Nîmes	Nîmes	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05319067 on ClinicalTrials.gov ↗ ← All trials in France