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 | Recruiting

• 1 other identifier: NIMAO/2021-2/AF-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Vesicoureteral Reflux 3

Keywords

Antibiotic prophylaxis; Microbiota

Outcome Measures

Primary Outcomes (1)

• α-diversity of the gut microbiota between groups

  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.

  Day 0

Secondary Outcomes (3)

• The β-diversity of the gut microbiota between groups

  Day 0

• The number of bacterial genera present in the gut microbiota between groups

  Day 0

• The prevalence of multi-resistant bacteria

  Day 0

Study Arms (3)

Cases

Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis

Other: Stool sampling

Controls

Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis

Other: Stool sampling

Healthy Controls

Healthy children aged 1 to 3 years.

Other: Stool sampling

Interventions

Stool sampling OTHER

Stool sample taken at home 24 hours before hospital visit

Cases; Controls; Healthy Controls

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

For the purpose of the study three groups of children will be constituted: Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis; Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis; Controls: Healthy children aged 1 to 3 years.

You may qualify if:

• 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.
• Child with grade 3 or higher vesicoureteral reflux.
• Child on trimethoprim-sulfamethoxazole therapy for at least 5 months.
• Child with uropathy and without long-term trimethoprim-sulfamethoxazole treatment.
• Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment.

You may not qualify if:

• 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 under court protection, guardianship or curatorship.
• Patient for whom it is impossible to give informed information to person with parental authority.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier

Montpellier, France

RECRUITING

CHU de Nîmes

Nîmes, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples

Study Officials

• Anne Filleron

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Filleron

CONTACT

04.66.68.32.86; anne.filleron@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: December 2, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

FR (2)