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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether peppermint oil can help children with bladder and bowel issues. The main goal is to determine if taking peppermint oil capsules three times a day for eight weeks improves symptoms. Participants will complete a questionnaire before and after the trial to track symptom changes. It suits children aged 8-17 who have bladder and bowel problems unresponsive to behavioral therapy, such as scheduled bathroom visits and diet changes, and who can swallow pills. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding a potential new treatment option for children.

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 prior data suggests that peppermint oil is safe for children with bladder and bowel dysfunction?

Research has shown that peppermint oil can affect the digestive system, including the food pipe, stomach, and large intestine. Studies have reported mild side effects, such as heartburn or allergic reactions, but these are rare. This suggests that peppermint oil is generally safe for use.

In this trial, children will take peppermint oil capsules for eight weeks. The study aims to determine if peppermint oil can help with bladder and bowel problems in kids. Although peppermint oil is not specifically approved for these issues, its use for other digestive problems suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using peppermint oil for bladder and bowel dysfunction in children because it offers a natural alternative to standard treatments, which often include medications like anticholinergics or laxatives. Peppermint oil is derived from a plant and contains menthol, which is known for its soothing properties and potential to relax the muscles of the bowel and bladder. This treatment is unique because it's delivered as a simple oil capsule, which can be more appealing and easier for children to tolerate compared to conventional pills or more invasive options. The excitement also stems from the possibility that peppermint oil could offer fewer side effects, making it a gentler option for young patients.

What evidence suggests that peppermint oil might be an effective treatment for bladder and bowel dysfunction in children?

Research shows that peppermint oil might help with bladder and bowel problems. Studies have found that peppermint oil can relax muscles in the digestive system, reducing cramps and discomfort. In one study with children, some experienced symptom relief from peppermint oil. It also seems to aid the small intestine and gallbladder, potentially easing digestive issues. This trial will investigate the potential benefits of peppermint oil for children with bladder and bowel dysfunction, building on existing evidence. ^{1 3 6 7 8}

Who Is on the Research Team?

Heidi A. Stephany, MD

Principal Investigator

Children's Hospital, Orange County

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-bladder-and-bowel-dysfunction-10-2022-97982

Peppermint Oil for Bladder and Bowel Dysfunction in ... Trial Overview The study tests if peppermint oil capsules taken three times daily can improve symptoms of bladder and bowel dysfunction in children. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5814329/

The physiologic effects and safety of Peppermint Oil and its ... Peppermint oil has been found to affect esophageal, gastric, small bowel, gallbladder, and colonic physiology.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1590865825009053

Mechanisms of action and clinical effectiveness of herbal ... This review assesses the clinical and preclinical evidence for herbal treatments used for patients with DGBI. Placebo-controlled trials show that specific ...

4. researchgate.net researchgate.net/publication/10922447_Effect_of_peppermint_oil_and_caraway_oil_on_gastrointestinal_motility_in_healthy_volunteers_A_pharmacodynamic_study_using_simultaneous_determination_of_gastric_and_gall-bladder_emptying_and_orocaecal_

Effect of peppermint oil and caraway oil on gastrointestinal ... Peppermint oil and caraway oil show a relaxing effect on the gall-bladder and the former slows small intestinal transit. Further studies should ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4443394/

Comparison of the Effects of pH-Dependent Peppermint Oil ... This placebo-controlled study was conducted on 120 children aged 4 - 13 years to compare the efficacy of pH-dependent peppermint oil (Colpermin) versus ...

6. researchgate.net researchgate.net/publication/335439104_Efficacy_and_Safety_of_Peppermint_Oil_in_a_Randomized_Double-Blind_Trial_of_Patients_With_Irritable_Bowel_Syndrome

Efficacy and Safety of Peppermint Oil in a Randomized ... Peppermint oil has been found to affect oesophageal, gastric, small bowel, gall-bladder, and colonic physiology. It has been used to ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332222009489

Peppermint essential oil: its phytochemistry, biological ... Urinary crystals and high concentration of calcium oxalate induce tubular epithelial inflammation, which are the major risk factors for urolithiasis. PEO may ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29372567/

the physiological effects and safety of peppermint oil and its ... Peppermint oil has been found to affect oesophageal, gastric, small bowel, gall-bladder, and colonic physiology.