Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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

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Irritable Bowel Syndrome Functional Abdominal Pain Syndrome Child Adolescent Therapeutics Adverse Drug Event

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are randomized in three groups: 1) peppermint oil capsules, 2) placebo), peppermint sweets

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Peppermint oil capsules and placebo are double blinded, peppermint sweets are open-label

Study Groups

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Peppermint oil capsules (Tempocol®)

Enteric-coated capsule containing 182mg of Peppermint Oil that release the oil in the small intestine, to be taken orally.

Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks

Group Type EXPERIMENTAL

Small intestinal release peppermint oil

Intervention Type DRUG

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.

Placebo

Capsule containing microcrystalline cellulose, to be taken orally. Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule containing microcrystalline cellulose

Peppermint sweets (Wilhelmina®)

Wilhelmina® peppermints contain 9.2 mg of Menthae Piperitae Aetheroleum (peppermint oil), and 18.4 Kcal per mint and are to be taken orally.

Age: 8-11 years old: 2 times daily for 8 weeks, if needed upped to 3 times daily after 4 weeks Age: 12-18: 3 times daily for 8 weeks, if needed upped to 3 times two capsules daily after 4 weeks

Group Type EXPERIMENTAL

Peppermint sweets

Intervention Type DRUG

Wilhelmina® peppermints contain 9.2 mg of Menthae Piperitae Aetheroleum (peppermint oil), and 18.4 Kcal per mint and are to be taken orally.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Placebo

Capsule containing microcrystalline cellulose

Intervention Type DRUG

Other Intervention Names

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Peppermint oil Menthae piperitae aetheroleum Tempocol® A03AX15 Wilhelmina®

Eligibility Criteria

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Inclusion Criteria

* Children aged between 8 years and 18 years
* Diagnosis of IBS or FAP-NOS according to the Rome IV criteria. According to these criteria, organic disorders will be ruled out after routine laboratory testing initiated by their general practitioner or treating physician as part of standard of care. In patients without alarm symptoms only celiac screening (anti-transglutaminase antibodies and IgA), and faecal calprotectin are necessary.37 In patients with diarrhea faecal testing for Giardia Lambliae will be added. If alarm symptoms are present, further diagnostic testing (like a full blood count, CRP, liver tests or an ultrasound) to rule out an organic disorder, is left to the discretion of the treating physician.
* An average daily pain rate of ≥ 3 of 10 on the Wong Baker Faces Pain Scale (This is a validated pain scale to measure pain intensity).

Informed Consent by both parents and by children aged ≥ 12 years. No informed consent from parents is necessary for children \>16 years.

Exclusion Criteria

* Current treatment by another health care professional for abdominal symptoms
* Previous use of peppermint oil for these abdominal complaints
* Known hypersensitivity to mints or peppermint oil
* Gastrointestinal blood loss
* Recurrent or unexplained fevers
* Decreased growth velocity
* History of previous abdominal surgeries in the past 3 months
* Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study
* Known concomitant organic gastrointestinal disease
* Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, mebeverine and Iberogast. If laxatives are being used (in patients with IBS-C) they can continue using them during the study.
* Current use of proton-pump inhibitors
* Insufficient knowledge of the Dutch language
* Pregnancy or current lactation. Women with childbearing potential must have a negative urine pregnancy test within 7 days prior to first dose of study treatment

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No