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

Primary Purpose

Bladder and Bowel Dysfunction

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peppermint Oil
Sponsored by
Children's Hospital of Orange County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder and Bowel Dysfunction

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital, Orange County

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peppermint Oil

Arm Description

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).

Outcomes

Primary Outcome Measures

Symptom score
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.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2022
Last Updated
January 12, 2023
Sponsor
Children's Hospital of Orange County
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1. Study Identification

Unique Protocol Identification Number
NCT05613153
Brief Title
Peppermint Oil as a Treatment for Children With Bladder and Bowel Dysfunction
Official Title
Peppermint Oil as an Alternative Treatment for Children With Bladder and Bowel Dysfunction: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Orange County

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder and Bowel Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peppermint Oil
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Peppermint Oil
Intervention Description
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 Outcome Measure Information:
Title
Symptom score
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi A. Stephany, MD
Organizational Affiliation
Children's Hospital, Orange County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Peppermint Oil as a Treatment for Children With Bladder and Bowel Dysfunction

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