Actively Recruiting

Age: 5Years - 17Years
All Genders
Healthy Volunteers
NCT07535619

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

Led by Aalborg University Hospital · Updated on 2026-04-17

110

Participants Needed

4

Research Sites

285 weeks

Total Duration

On this page

Sponsors

A

Aalborg University Hospital

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with overactive bladder diagnosed according to International Children's Continence Society criteria (cases only)
  • Children with at least two wet days per week (cases only)
  • Children with no prior pharmacological treatment of overactive bladder and daytime urinary incontinence (cases only)
  • Healthy children with no lower urinary tract symptoms (healthy participants only)
  • Negative urine dipstick test
Not Eligible

You will not qualify if you...

  • Known urogenital abnormalities affecting lower urinary tract function
  • Known gastrointestinal or neurological diseases
  • Use of systemic drugs within five half-lives of the drug
  • Use of systemic antibiotics within three months before inclusion
  • Current urinary tract infection
  • Urinary tract infection within the last three months prior to inclusion
  • Current constipation
  • Abnormal uroflowmetry (healthy participants only)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Department of Pediatrics, Aalborg University Hospital

Aalborg, Denmark, 9000

Actively Recruiting

2

Department of Pediatrics, Aarhus University Hospital

Aarhus, Denmark, 8200

Not Yet Recruiting

3

Department of Pediatrics, Regional Hospital West Jutland

Herning, Denmark, 7400

Actively Recruiting

4

Department of Pediatrics, North Denmark Regional Hospital

Hjørring, Denmark, 9800

Not Yet Recruiting

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Research Team

K

Kristina Thorsteinsson, MD

CONTACT

S

Søren Hagstrøm, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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