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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-17
SponsorAalborg University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

110 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Aalborg University Hospital

Lead sponsor

Aarhus University Hospital

Collaborator

Regional Hospital West Jutland

Collaborator

Regionshospital Nordjylland

Collaborator