Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis … (NCT05319067) | Clinical Trial Compass
RecruitingNot Applicable
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
France150 participantsStarted 2022-12-02
Plain-language 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.
Who can participate
Age range
1 Year – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is observational and measures gut bacteria diversity rather than testing a new treatment, what would my child actually need to do — like stool sample collections or clinic visits — and how would that fit into our routine care schedule?
2My child has Grade 3 or higher vesicoureteral reflux and is already on long-term antibiotic prophylaxis — is that exactly the situation this study is looking at, and does our current treatment plan match what they're enrolling for?
3This study is comparing gut microbiota in children on prolonged antibiotics versus two control groups, so what might we learn about the long-term effects of antibiotic prophylaxis on my child's gut health, and is that something we should be weighing when deciding whether to continue this treatment regardless of the study?
4Since this is a non-interventional study with no assigned treatment, are there any risks to my child from participating — for example, from the sample collection process — or is this essentially a data-only study?
5Are there alternative approaches to managing Grade 3 or higher vesicoureteral reflux, like surgical correction, that you'd recommend we consider alongside or instead of continuing long-term antibiotic prophylaxis, whether or not we join this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.