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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stool sampling.
- Who it may be relevant to
- Registry conditions: Vesicoureteral Reflux 3. Basic parameters: 1 year — 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Stool sampling
Stool sample taken at home 24 hours before hospital visit
Primary outcome measures
- α-diversity of the gut microbiota between groups [Time frame: Day 0]
Secondary outcome measures (3)
- The β-diversity of the gut microbiota between groups [Time frame: Day 0]
- The number of bacterial genera present in the gut microbiota between groups [Time frame: Day 0]
- The prevalence of multi-resistant bacteria [Time frame: Day 0]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 2 centers
- CHU de Montpellier — Montpellier
- CHU de Nîmes — Nîmes
Identifiers
NCT: NCT05319067 · NIMAO/2021-2/AF-01