Vesicoureteral Reflux 3PROPHYBIOTANCT05319067
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
An observational study of Vesicoureteral Reflux 3, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Vesicoureteral Reflux 3
- What is being tested?
- Stool sampling
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Dec 2022to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de Montpellier
Montpellier
Denis Morin, 04.67.33.64.28, d-morin@chu-montpellier.fr
Denis Morin
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Anne Filleron
About this study
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.
Read more
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
- Being tested
- Stool sampling
- Keywords
- Antibiotic prophylaxis, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplingOther
Stool sample taken at home 24 hours before hospital visit
| Study group | Role | What they receive |
|---|---|---|
| Cases | Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis Receives: Other: Stool sampling | |
| Controls | Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis Receives: Other: Stool sampling | |
| Healthy Controls | Healthy children aged 1 to 3 years. Receives: Other: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (3)
The β-diversity of the gut microbiota between groups
Operational Taxonomic Units measured by Bray Curtis Index
Measured: Day 0
The number of bacterial genera present in the gut microbiota between groups
Relative abundance Operational Taxonomic Units present
Measured: Day 0
The prevalence of multi-resistant bacteria
% of isolated bacteria producing extended spectrum betalactamase, carbapenemase-producing Enterococcus faecium and glycopeptide-resistant Enterococcus faecium and bacteria resistant to trimethoprim-sulfamethoxazole
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start2 Dec 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral Reflux 3Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Filleron, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319067
- Sponsor's protocol ID
- NIMAO/2021-2/AF-01
- Acronym
- PROPHYBIOTA
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05319067
- Acronym / sponsor ID
- PROPHYBIOTA / NIMAO/2021-2/AF-01
- Conditions
- Vesicoureteral Reflux 3
- Keywords
- Antibiotic prophylaxis, Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Stool samplingChildren aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis |
| Controls | – | Other: Stool samplingChildren aged 1 to 3 years with uropathy, without antibiotic prophylaxis |
| Healthy Controls | – | Other: Stool samplingHealthy children aged 1 to 3 years. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool samplingStool sample taken at home 24 hours before hospital visit | Other | Cases, Controls, Healthy Controls |
Primary outcome
α-diversity of the gut microbiota between groups
Time frame: Day 0
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Filleron principal investigator
CHU de Nimes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vesicoureteral Reflux 3, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Filleron (04.66.68.32.86, anne.filleron@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
α-diversity of the gut microbiota between groups (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.