Antibiotics for reflux may reshape Kids' gut bacteria
NCT ID NCT05319067
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at gut bacteria diversity in children aged 1 to 3 who take long-term antibiotics for a condition called vesicoureteral reflux (urine flowing backward into the kidneys). Researchers will compare their gut bacteria to two other groups: children with the same condition not on antibiotics, and healthy children. The goal is to understand how prolonged antibiotic use changes the gut microbiome, which may affect immune health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could reveal how long-term antibiotics affect gut bacteria in young children, potentially guiding future treatment decisions.
- What could go wrong
- This is an observational study, not a treatment trial. It only measures differences in gut bacteria, so it won't directly lead to new therapies or cures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2022
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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1 year to 3 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Montpellier
RECRUITINGMontpellier, France
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CHU de Nîmes
RECRUITINGNîmes, France