The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.

Recruiting now

Conditions studied: Urinary Incontinence, Daytime Wetting, Urination Disorders, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations, Elimination Disorders, Behavioral Symptoms

In brief

The aim of this study is to investigate whether the voided urinary, perineal/preputial, and the fecal microbiota are different between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the study aims to investigate if the microbiota is different according to the severity of DUI and if the microbiota is changed throughout treatment of DUI. A follow-up study will as well be performed on healthy children to investigate how the microbiota evolves with increasing age and pubertal stage. Children with OAB and DUI will be recruited from involved pediatric departments, and specimen in the form of urine, perineal/preputial swabs, and feces will be collected according to the protocol.

Key facts

Study ID

NCT07535619

Run by

Aalborg University Hospital

People needed

110

Starts

2022-12-14

Expected to finish

2028-06-01

Last updated by the study team

2026-04-17

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Department of Pediatrics, Aalborg University Hospital — Aalborg, Denmark (enrolling)
• Department of Pediatrics, Regional Hospital West Jutland — Herning, Denmark (enrolling)
• Department of Pediatrics, Aarhus University Hospital — Aarhus, Denmark
• Department of Pediatrics, North Denmark Regional Hospital — Hjørring, Denmark

Full record on ClinicalTrials.gov

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