Urine, perineal, and stool microbiota in children and adolescents
Official title: The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children and Adolescents - the PpUF-study.
Run by Aalborg University Hospital · NCT07535619 · Data updated 2026-11-12
We will test whether the bacteria in voided urine, around the genitals, and in stool differ between children with overactive bladder or daytime wetting and healthy children of the same age and gender.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 17 Years |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Status | Recruiting |
| Started | December 14, 2022 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07535619 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents diagnosed with overactive bladder or daytime urinary incontinence who have at least two wet days per week, no prior pharmacologic treatment for OAB/DUI, a negative urine dipstick, and no recent antibiotic use are ideal candidates.
✕Probably not a fit
Children with known urogenital abnormalities, gastrointestinal or neurological diseases, recent systemic antibiotic use, current or recent urinary tract infection, or current constipation are unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will recruit children and adolescents with overactive bladder/daytime urinary incontinence and age- and gender-matched healthy controls from pediatric departments in Denmark. Voided urine, perineal/preputial swabs, and fecal samples will be collected and processed for bacterial community profiling using Illumina MiSeq sequencing. Analyses will compare microbiota composition between cases and controls, by severity of daytime urinary incontinence, and over the course of treatment in affected children. A longitudinal follow-up of healthy participants will also examine how the microbiota changes with increasing age and pubertal stage.
Why it matters
Potential benefit: If differences are found, the results could point to new diagnostic markers or microbiota-targeted approaches to reduce urinary symptoms in children.
How similar studies have gone: Adult microbiome sequencing studies have suggested links between urinary and fecal dysbiosis and OAB, but comparable pediatric data are limited and this pediatric sequencing approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Overactive bladder as per International Children's Continence Society criteria (cases only). * At least two wet days per week (cases only). * No prior pharmacological treatment of OAB and DUI (cases only). * No lower urinary tract symptoms (healthy participants only). * Negative urine dipstick test Exclusion Criteria: * No known urogenital abnormality affecting the lower urinary tract function. * No known gastrointestinal or neurological diseases. * No use of systemic drugs within five half-lives of the drug. * No use of systemic antibiotics within three months before inclusion * No current urinary tract infection. * No urinary tract infection within the last three months prior to inclusion. * No current constipation. * Abnormal uroflowmetry (healthy participants only).
Where it's running
-
Department of Pediatrics, Aalborg University Hospital
Aalborg, Denmark Recruiting -
Department of Pediatrics, Regional Hospital West Jutland
Herning, Denmark Recruiting -
Department of Pediatrics, Aarhus University Hospital
Aarhus, Denmark Not yet recruiting -
Department of Pediatrics, North Denmark Regional Hospital
Hjørring, Denmark Not yet recruiting
Study contacts
- Study coordinator: Kristina Thorsteinsson, MD
- Email: uroforsk@rn.dk
- Phone: +4597663372
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.