Actively Recruiting

Age: 1Year - 3Years
All Genders
Healthy Volunteers
NCT05319067

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

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-04-15

150

Participants Needed

2

Research Sites

286 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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

Who Can Participate

Age: 1Year - 3Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • The patient must be a member or beneficiary of a health insurance plan
  • Parent or guardian must not object to participation
  • Child must have a diversified diet
  • Child with grade 3 or higher vesicoureteral reflux and on trimethoprim-sulfamethoxazole therapy for at least 5 months (Group 1)
  • Child with uropathy not treated long-term with trimethoprim-sulfamethoxazole (Group 2)
  • Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment (Group 3)
Not Eligible

You will not qualify if you...

  • 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 or current treatment with methotrexate, biotherapies, or immunosuppressants
  • Participation in a category 1 trial likely to modify intestinal microbiota
  • In an exclusion period determined by another study
  • Under court protection, guardianship, or curatorship
  • Unable to provide informed consent from person with parental authority

AI-Screening

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Trial Site Locations

Total: 2 locations

1

CHU de Montpellier

Montpellier, France

Actively Recruiting

2

CHU de Nîmes

Nîmes, France

Actively Recruiting

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Research Team

A

Anne Filleron

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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