Peppermint Oil for Bladder and Bowel Dysfunction in Children

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Orange County

Must not be taking: Oxybutynin, Reflux medications

Disqualifiers: Neurogenic bladder, Tethered cord, Hydronephrosis, Vesicoureteral reflux, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether peppermint oil can help children with bladder and bowel problems. Children will take peppermint oil capsules regularly for a few months. Researchers will check if their symptoms improve. Peppermint oil has been studied for its effects on irritable bowel syndrome and other gastrointestinal issues.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken oxybutynin in the last 30 days or are on medications for hiatal hernia, severe gastrointestinal reflux, or gallbladder disorders.

What data supports the effectiveness of the drug peppermint oil for bladder and bowel dysfunction in children?

Research shows that peppermint oil can help reduce pain in children with irritable bowel syndrome (IBS), which is a condition affecting the digestive system. This suggests that peppermint oil might also help with other bowel-related issues. ^{1 2 3 4 5}

Is peppermint oil safe for use in humans?

Peppermint oil has been studied in various forms and doses, primarily for irritable bowel syndrome, and is generally considered safe for short-term use in humans. Some studies have shown it can cause mild side effects like heartburn or allergic reactions, but these are not common. ^{1 2 3 5 6}

How is peppermint oil different from other treatments for bladder and bowel dysfunction in children?

Peppermint oil is unique because it is a natural remedy that may help relax the muscles of the bladder and bowel, potentially improving symptoms without the use of traditional medications. Unlike standard treatments, which often focus on managing symptoms with drugs or behavioral therapies, peppermint oil offers a novel approach by utilizing its natural muscle-relaxing properties. ^{7 8 9 10 11}

Research Team

Heidi A. Stephany, MD

Principal Investigator

Children's Hospital, Orange County

Eligibility Criteria

This trial is for children aged 8-17 who weigh at least 30kg and have bladder and bowel dysfunction not caused by nerve issues. They should have tried behavioral therapy without success and be able to swallow pills. It's not for kids with certain neurological conditions, severe urinary tract problems, learning disabilities, recent oxybutynin use, or gastrointestinal disorders.

Inclusion Criteria

I can swallow pills.

I am a child aged 8-17, weigh at least 30kg, and my bladder and bowel issues haven't improved with behavior therapy.

Exclusion Criteria

I weigh less than 30 kg.

I have taken oxybutynin in the last 30 days.

I have a hiatal hernia, severe GERD, or gallbladder issues, or I'm on medication for these.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peppermint oil capsules to be taken 3 times daily

8 weeks

1 visit (in-person) at baseline

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person) at 8 weeks

Treatment Details

Interventions

• Peppermint Oil

Trial Overview The study tests if peppermint oil capsules taken three times daily can improve symptoms of bladder and bowel dysfunction in children. The effectiveness will be measured using a questionnaire before starting treatment and after eight weeks of taking the oil.

Participant Groups

Group I: Peppermint Oil Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

Children's Hospital of Orange County

Lead Sponsor

Trials

38

Recruited

5,700+

References

1. United States pubmed.ncbi.nlm.nih.gov

Enteric-coated, pH-dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Peppermint oil (Mintoil) in the treatment of irritable bowel syndrome: a prospective double blind placebo-controlled randomized trial. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Gastrointestinal clinical pharmacology of peppermint oil. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Novel Ileocolonic Release Peppermint Oil Capsule for Treatment of Irritable Bowel Syndrome: A Phase I Study in Healthy Volunteers. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of the management of bowel dysfunction in children with neuropathic lower urinary tract dysfunction and its effect on bladder dynamics. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Bladder and bowel dysfunction: evidence for multidisciplinary care. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Development of a Standardized Approach for the Assessment of Bowel and Bladder Dysfunction. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The impact of bowel and bladder problems on children's quality of life and their parents: A scoping review. [2019]

11. Norway pubmed.ncbi.nlm.nih.gov

Bladder and bowel dysfunction and the resolution of urinary incontinence with successful management of bowel symptoms in children. [2013]