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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05319067
Acronym
PROPHYBIOTA
Enrollment
150
Registered
2022-04-08
Start date
2022-12-02
Completion date
2028-06-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vesicoureteral Reflux 3

Keywords

Antibiotic prophylaxis, Microbiota

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 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.

Interventions

OTHERStool sampling

Stool sample taken at home 24 hours before hospital visit

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
α-diversity of the gut microbiota between groupsDay 0N 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.

Secondary

MeasureTime frameDescription
The β-diversity of the gut microbiota between groupsDay 0Operational Taxonomic Units measured by Bray Curtis Index
The number of bacterial genera present in the gut microbiota between groupsDay 0Relative abundance Operational Taxonomic Units present
The prevalence of multi-resistant bacteriaDay 0% of isolated bacteria producing extended spectrum betalactamase, carbapenemase-producing Enterococcus faecium and glycopeptide-resistant Enterococcus faecium and bacteria resistant to trimethoprim-sulfamethoxazole

Countries

France

Contacts

CONTACTAnne Filleron
anne.filleron@chu-nimes.fr04.66.68.32.86
PRINCIPAL_INVESTIGATORAnne Filleron

CHU de Nimes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026