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

Sponsor

Children's Hospital of Orange County (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05613153

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder and Bowel Dysfunction	Dietary Supplement: Peppermint Oil	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Dietary Supplement: Peppermint Oil 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.

Arm

Intervention/Treatment

Experimental: 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).

Dietary Supplement: Peppermint Oil

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital, Orange County	Orange	California	United States	92868

Sponsors and Collaborators

Children's Hospital of Orange County

Investigators

Principal Investigator: Heidi A. Stephany, MD, Children's Hospital, Orange County

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Children's Hospital of Orange County

ClinicalTrials.gov Identifier:

NCT05613153

Other Study ID Numbers:

2206102

First Posted:

Nov 14, 2022

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Gastrointestinal Diseases

Peppermint oil

Study Results

No Results Posted as of Jan 17, 2023