Trials / Completed
CompletedNCT05799053
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 228 (actual)
- Sponsor
- St. Antonius Hospital · Academic / Other
- Sex
- All
- Age
- 8 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS) symptoms in adults. Few studies of low quality are performed in an paediatric setting. Therefore, the investigators will conduct a multicenter randomized, placebo controlled trial to investigate the effects of an eight-week peppermint oil treatment in paediatric IBS or Functional Abdominal Pain - Not otherwise specified (FAP-NOS) patients.
Detailed description
The objective of the MINT study is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules in reducing abdominal pain intensity in children with IBS or FAP-NOS. In addition, we evaluate the effect of peppermint oil capsules compared to placebo capsules on other disease-related outcome measures such as anxiety \& depression, quality of life, absenteeism from school, and healthcare costs. The second aim is to explore the effectiveness of regular mints in reducing abdominal pain intensity compared to peppermint oil capsules and placebo capsules and the effect of mints on secondary outcome parameters.
Conditions
- Irritable Bowel Syndrome
- Functional Abdominal Pain Syndrome
- Child
- Adolescent
- Therapeutics
- Adverse Drug Event
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Small intestinal release peppermint oil | Tempocol®, a gastric acid resistant (enteric-coated) capsule containing 182mg of Menthae Piperitae Aetheroleum (peppermint oil), is currently registered as an over the counter prescription drug on the Dutch market for treatment of abdominal pain, discomfort or flatulence. |
| DRUG | Peppermint sweets | Wilhelmina® peppermints contain 9.2 mg of Menthae Piperitae Aetheroleum (peppermint oil), and 18.4 Kcal per mint and are to be taken orally. |
| DRUG | Placebo | Capsule containing microcrystalline cellulose |
Timeline
- Start date
- 2022-05-12
- Primary completion
- 2024-11-30
- Completion
- 2024-11-30
- First posted
- 2023-04-05
- Last updated
- 2025-05-30
Locations
3 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05799053. Inclusion in this directory is not an endorsement.