Bladder and Bowel DysfunctionNCT05613153
Peppermint Oil as a Treatment for Children With Bladder and Bowel Dysfunction
A study testing Peppermint Oil in people with Bladder and Bowel Dysfunction, run by Children's Hospital of Orange County at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Bladder and Bowel Dysfunction
- What is being tested?
- Peppermint Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital, Orange County
Orange, California, 92868
About this study
Official title: Peppermint Oil as an Alternative Treatment for Children With Bladder and Bowel Dysfunction: A Prospective Study
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?
Read more
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.
- Conditions
- Bladder and Bowel Dysfunction
- Being tested
- Peppermint Oil
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint OilDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Peppermint Oil | Experimental | 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). Receives: Dietary Supplement: Peppermint Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Bladder and Bowel DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heidi A. Stephany, MD, Principal investigator, Children's Hospital, Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613153
- Sponsor's protocol ID
- 2206102
- Status last verified
- Mar 2026
- First submitted
- 4 Nov 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vaz GT, Vasconcelos MM, Oliveira EA, Ferreira AL, Magalhaes PG, Silva FM, Lima EM. Prevalence of lower urinary tract symptoms in school-age children. Pediatr Nephrol. 2012 Apr;27(4):597-603. doi: 10.1007/s00467-011-2028-1. Epub 2011 Oct 4.
PubMed 21969094Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3.
PubMed 16753432Jiang R, Kelly MS, Routh JC. Assessment of pediatric bowel and bladder dysfunction: a critical appraisal of the literature. J Pediatr Urol. 2018 Dec;14(6):494-501. doi: 10.1016/j.jpurol.2018.08.010. Epub 2018 Aug 28.
PubMed 30297226Landgraf JM, Abidari J, Cilento BG Jr, Cooper CS, Schulman SL, Ortenberg J. Coping, commitment, and attitude: quantifying the everyday burden of enuresis on children and their families. Pediatrics. 2004 Feb;113(2):334-44. doi: 10.1542/peds.113.2.334.
PubMed 14754946Hagglof B, Andren O, Bergstrom E, Marklund L, Wendelius M. Self-esteem before and after treatment in children with nocturnal enuresis and urinary incontinence. Scand J Urol Nephrol Suppl. 1997;183:79-82.
PubMed 9165615Varlam DE, Dippell J. Non-neurogenic bladder and chronic renal insufficiency in childhood. Pediatr Nephrol. 1995 Feb;9(1):1-5. doi: 10.1007/BF00858952.
PubMed 7742205Bower WF, Yew SY, Sit KY, Yeung CK. Half-day urotherapy improves voiding parameters in children with dysfunctional emptying. Eur Urol. 2006 Mar;49(3):570-4. doi: 10.1016/j.eururo.2005.12.001. Epub 2006 Jan 4.
PubMed 16420968Arlen AM. Dysfunctional Voiders-Medication Versus Urotherapy? Curr Urol Rep. 2017 Feb;18(2):14. doi: 10.1007/s11934-017-0656-0.
PubMed 28213858Lazarus J. Intravesical oxybutynin in the pediatric neurogenic bladder. Nat Rev Urol. 2009 Dec;6(12):671-4. doi: 10.1038/nrurol.2009.214. Epub 2009 Nov 10.
PubMed 19901914Donnellan CA, Fook L, McDonald P, Playfer JR. Oxybutynin and cognitive dysfunction. BMJ. 1997 Nov 22;315(7119):1363-4. doi: 10.1136/bmj.315.7119.1363. No abstract available.
PubMed 9402781Ekhart C, Vries T, Hunsel FV. Psychiatric adverse drug reactions in the paediatric population. Arch Dis Child. 2020 Aug;105(8):749-755. doi: 10.1136/archdischild-2019-317933. Epub 2020 Feb 14.
PubMed 32060030Alammar N, Wang L, Saberi B, Nanavati J, Holtmann G, Shinohara RT, Mullin GE. The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. BMC Complement Altern Med. 2019 Jan 17;19(1):21. doi: 10.1186/s12906-018-2409-0.
PubMed 30654773Kline RM, Kline JJ, Di Palma J, Barbero GJ. Enteric-coated, pH-dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. J Pediatr. 2001 Jan;138(1):125-8. doi: 10.1067/mpd.2001.109606.
PubMed 11148527Korterink JJ, Rutten JM, Venmans L, Benninga MA, Tabbers MM. Pharmacologic treatment in pediatric functional abdominal pain disorders: a systematic review. J Pediatr. 2015 Feb;166(2):424-31.e6. doi: 10.1016/j.jpeds.2014.09.067. Epub 2014 Nov 8.
PubMed 25449223Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
PubMed 25772695
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peppermint Oil as an Alternative Treatment for Children With Bladder and Bowel Dysfunction: A Prospective Study
- ClinicalTrials.gov ID
- NCT05613153
- Acronym / sponsor ID
- 2206102
- Conditions
- Bladder and Bowel Dysfunction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peppermint Oil | Experimental | Dietary Supplement: Peppermint OilPeppermint 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). |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peppermint OilParticipants 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. | Dietary supplement | Peppermint Oil |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 21969094Vaz GT, Vasconcelos MM, Oliveira EA, Ferreira AL, Magalhaes PG, Silva FM, Lima EM. Prevalence of lower urinary tract symptoms in school-age children. Pediatr Nephrol. 2012 Apr;27(4):597-603. doi: 10.1007/s00467-011-2028-1. Epub 2011 Oct 4.
- Background: PubMed 16753432Neveus T, von Gontard A, Hoebeke P, Hjalmas K, Bauer S, Bower W, Jorgensen TM, Rittig S, Walle JV, Yeung CK, Djurhuus JC. The standardization of terminology of lower urinary tract function in children and adolescents: report from the Standardisation Committee of the International Children's Continence Society. J Urol. 2006 Jul;176(1):314-24. doi: 10.1016/S0022-5347(06)00305-3.
- Background: PubMed 30297226Jiang R, Kelly MS, Routh JC. Assessment of pediatric bowel and bladder dysfunction: a critical appraisal of the literature. J Pediatr Urol. 2018 Dec;14(6):494-501. doi: 10.1016/j.jpurol.2018.08.010. Epub 2018 Aug 28.
- Background: PubMed 14754946Landgraf JM, Abidari J, Cilento BG Jr, Cooper CS, Schulman SL, Ortenberg J. Coping, commitment, and attitude: quantifying the everyday burden of enuresis on children and their families. Pediatrics. 2004 Feb;113(2):334-44. doi: 10.1542/peds.113.2.334.
- Background: PubMed 9165615Hagglof B, Andren O, Bergstrom E, Marklund L, Wendelius M. Self-esteem before and after treatment in children with nocturnal enuresis and urinary incontinence. Scand J Urol Nephrol Suppl. 1997;183:79-82.
- Background: PubMed 7742205Varlam DE, Dippell J. Non-neurogenic bladder and chronic renal insufficiency in childhood. Pediatr Nephrol. 1995 Feb;9(1):1-5. doi: 10.1007/BF00858952.
- Background: PubMed 16420968Bower WF, Yew SY, Sit KY, Yeung CK. Half-day urotherapy improves voiding parameters in children with dysfunctional emptying. Eur Urol. 2006 Mar;49(3):570-4. doi: 10.1016/j.eururo.2005.12.001. Epub 2006 Jan 4.
- Background: PubMed 28213858Arlen AM. Dysfunctional Voiders-Medication Versus Urotherapy? Curr Urol Rep. 2017 Feb;18(2):14. doi: 10.1007/s11934-017-0656-0.
- Background: PubMed 19901914Lazarus J. Intravesical oxybutynin in the pediatric neurogenic bladder. Nat Rev Urol. 2009 Dec;6(12):671-4. doi: 10.1038/nrurol.2009.214. Epub 2009 Nov 10.
- Background: PubMed 9402781Donnellan CA, Fook L, McDonald P, Playfer JR. Oxybutynin and cognitive dysfunction. BMJ. 1997 Nov 22;315(7119):1363-4. doi: 10.1136/bmj.315.7119.1363. No abstract available.
- Background: PubMed 32060030Ekhart C, Vries T, Hunsel FV. Psychiatric adverse drug reactions in the paediatric population. Arch Dis Child. 2020 Aug;105(8):749-755. doi: 10.1136/archdischild-2019-317933. Epub 2020 Feb 14.
- Background: PubMed 30654773Alammar N, Wang L, Saberi B, Nanavati J, Holtmann G, Shinohara RT, Mullin GE. The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. BMC Complement Altern Med. 2019 Jan 17;19(1):21. doi: 10.1186/s12906-018-2409-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heidi A. Stephany, MD principal investigator
Children's Hospital, Orange County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint Oil in people with Bladder and Bowel Dysfunction, run by Children's Hospital of Orange County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05613153, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.