Peppermint Oil As a Treatment for Children with Bladder and Bowel Dysfunction

Not Applicable

• Conditions: Bladder and Bowel Dysfunction
• Interventions: Dietary Supplement: Peppermint Oil

• Registration Number: NCT05613153
• Lead Sponsor: Children's Hospital of Orange County

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peppermint Oil	Peppermint Oil	Peppermint oil will be provided free of charge to participants under the trademark Pepogest produced by the maker Nature's Way® (dosage 0.2 mL, 181 mg peppermint oil).

Primary Outcome Measures

Name	Time	Method
Symptom score	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.

Trial Locations

Locations (1)

Children's Hospital, Orange County; 🇺🇸 Orange, California, United States