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Enrolling by Invitation

NCT Number: NCT05613153

Peppermint Oil as a Treatment for Children With Bladder and Bowel Dysfunction

The goal of this clinical trial is to study the effect of peppermint oil in in children with bladder and bowel dysfunction.

The main question it aims to answer is: Does peppermint oil improve symptoms of bladder and bowel dysfunction among children?

Participants will:

* Be provided peppermint oil capsules to be taken 3 times daily for 8 weeks. * At baseline and at a follow-up visit (8 weeks later), participants will be asked to complete the Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire.

Researchers will compare baseline and follow-up questionnaire data for each participant to determine if there is improvement in symptoms of bladder and bowel dysfunction.

Enrolling by Invitation

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Orange County

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 8-17 years and weighing 30kg or more with non-neurogenic bladder and bowel dysfunction who have failed behavioral therapy. Behavioral therapy, or also termed standard urotherapy, is defined as encompassing the following components [15]: Information and demystification; instruction on avoidance of holding maneuvers, regular bowel habits, proper voiding posture; lifestyle advice encompassing balanced fluid intake and diet, diminished caffeine, regular bladder and bowel emptying patterns; registration of symptoms and voiding habits with bladder diaries or frequency-volume charts; support and encouragement via regular follow up with caregiver. Failure of behavioral therapy is defined as no symptomatology improvement after adherence to behavioral therapy after 6 weeks.
  • Participants must be able to swallow pills

Exclusion criteria

  • Patients with neurogenic bladder, tethered cord, Society of Fetal Urology grade 3-4 hydronephrosis, vesicoureteral reflux, learning disabilities, or those who have undergone surgical therapy for bladder and bowel dysfunction will be excluded.
  • Patients on medical therapy with oxybutynin within the last 30 days.
  • Patients with hiatal hernia, severe gastrointestinal reflux or gallbladder disorders or on medications for these conditions will be excluded.
  • Patient weighing less than 30 kg.

Treatment and study plan

peppermint oil

Dietary Supplement

Participants weighing more than 40 kg will receive 2 peppermint oil capsules 3 times a day. Smaller children who weigh between 30 kg and 40 kg will receive 1 capsule of peppermint oil 3 times a day. All subjects will receive 8 weeks of treatment.

Primary outcomes

  1. Symptom score

    Time frame: 8 weeks

    Vancouver Nonneurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome Questionnaire Score. This includes 13 items scored using a 5-point Likert scale for each item. A score of 0 denotes no complaints and a score of 4 indicates severe symptoms. Range of scores 0-54, with higher scores indicating a worse outcome.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Orange County

Other

Registry information

Official study title

Peppermint Oil as an Alternative Treatment for Children With Bladder and Bowel Dysfunction: A Prospective Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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