Irritable Bowel SyndromePhase 3MINTNCT05799053
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
A Phase 3 study testing Small intestinal release peppermint oil and Peppermint sweets in people with Irritable Bowel Syndrome and Functional Abdominal Pain Syndrome, run by St. Antonius Hospital at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Child
- What is being tested?
- Small intestinal release peppermint oil and Peppermint sweets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 3 sitesNetherlands
- Study dates
- 12 May 2022to 30 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
De KinderKliniek
Almere Stad, Flevoland, 1315 RC
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Amphia Hospital
Breda, North Brabant, 4818 CK
About this study
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.
Read the 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
- Being tested
- Small intestinal release peppermint oil, Peppermint sweets, Placebo
- Keywords
- Peppermint oil, Irritable Bowel Syndrome, Functional Abdominal Pain - Not Otherwise Specified, Paediatrics
- Medical subject headings
- Irritable Bowel Syndrome, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small intestinal release peppermint oilDrug
Also called Peppermint oil, Menthae piperitae aetheroleum, Tempocol®, A03AX15
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.
Peppermint sweetsDrug
Also called 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.
PlaceboDrug
Capsule containing microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Peppermint oil capsules (Tempocol®) | Experimental | 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 Receives: Drug: Small intestinal release peppermint oil |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
| Peppermint sweets (Wilhelmina®) | Experimental | 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 Receives: Drug: Peppermint sweets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain intensity response rate after 8 weeks of treatment
The proportion of patients with ≥ 30% reduction of their abdominal pain intensity after 8 weeks of therapy compared to baseline. This will be assessed by a smartphone diary app, on which patients record daily at the end of the day the intensity of their abdominal pain during a period of 7 consecutive days using a 10 point Likert scale/Wong-Baker faces scale. A score of 0 correlates with no pain and a score of 10 correlates with the worst imaginable pain. The intensity scores of 7 days will be summed up.
Measured: 8 weeks
Secondary outcomes (17)
Change in pain duration
Abdominal pain duration will be scored in minutes of abdominal pain per day during 7 consecutive days after 8 weeks of therapy compared to baseline
Measured: 4 weeks, 8 weeks, 12 weeks
Change in pain frequency
Abdominal pain frequency will be scored as the average amount of days with pain during 7 consecutive days after 8 weeks of therapy compared to baseline
Measured: 4 weeks, 8 weeks, 12 weeks
Change in abdominal pain intensity
Abdominal pain intensity will be scored using a 10-point Wong-Baker faces scale during 7 consecutive days after 8 weeks of therapy compared to baseline
Measured: 4 weeks, 8 weeks, 12 weeks
Change in Quality of Life
Change in quality of live will be measured with the PedsQL after 8 weeks of therapy compared to baseline
Measured: 8 weeks
Change in depression and anxiety score
Depression and anxiety scores are measured by the Revised Anxiety and Depression Scale-short version (RCADS-25) after 8 weeks of therapy compared to baseline
Measured: 8 weeks
School absences during the treatment
Hours of school absence in the previous week are measured.
Measured: 4 weeks, 8 weeks, 12 weeks
Use of pain rescue medication during the treatment
Use of pain rescue medication like paracetamol or NSAIDs
Measured: 4 weeks, 8 weeks, 12 weeks
Expectancy of treatment
expectations of both parents separately of the treatment on a scale of 0 (no improvement) to 10 (very much improved)
Measured: 0 weeks
Expectancy of treatment
the child's expectations of the treatment on a scale of 0 (no improvement) to 10 (very much improved)
Measured: 0 weeks
Change in defecation pattern
Change in defecation pattern is recorded as the daily stool frequency and consistency according to the Bristol Stool Scale
Measured: 4 weeks, 8 weeks, 12 weeks
Adequate relief
patients will be asked whether they have adequate relief of IBS/FAP-NOS symptoms using a single question ("Did you have adequate relief of IBS/FAP-NOS symptoms (abdominal discomfort/pain, bowel habits, and other symptoms like nausea and bloating) over the past week?") scored on a dichotomous scale (Yes/No)
Measured: 4 weeks, 8 weeks, 12 weeks
Health status
the EQ-5D-Y is a standardised questionnaire on health-related quality of life and will be used in the cost-effectiveness and cost-utility analysis
Measured: 8 weeks
Costs
iMCQ and the iPCQ will be used to measure the direct and indirect costs due to health care utilization and work absenteeism by parents
Measured: 8 weeks, 12 weeks
Safety of peppermint oil
incidence of adverse events will be reported by the participants
Measured: 4 weeks, 8 weeks, 12 weeks
Ease of use of peppermint oil capsules, placebo capsules or peppermint sweets
Ease of use of capsules or sweets will be scored after 8 weeks using a 5-point Likert scale with the following statement: the pills were easy to use and swallow: strongly disagree/disagree/neither agree nor disagree/agree/strongly agree.
Measured: 8 weeks
Taste of peppermint oil capsules, placebo capsules or peppermint sweets
taste of capsules or sweets will be scored after 8 weeks using a Likert scale: I like the taste of the pills: strongly disagree/disagree/neither agree nor disagree/agree/strongly agree.
Measured: 8 weeks
Placebo genes
Several other single nucleotide polymorphisms (SNPs) were found to influence response to placebo treatment. Therefore, we will investigate whether SNPs in a candidate set of genes (previously associated with either the placebo response in adults) are related to either placebo response or treatment response in children with IBS or FAP-NOS.
Measured: 0 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start12 May 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized in three groups: 1) peppermint oil capsules, 2) placebo), peppermint sweets
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Vermeijden, St. Antonius Hospital
- Investigators
- Arine Vlieger, MD, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799053
- Sponsor's protocol ID
- NL78304.100.21
- Acronym
- MINT
- Status last verified
- Apr 2024
- First submitted
- 7 Feb 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vermeijden NK, van der Feen C, Groeneweg M, Hummel T, Zagers D, Bertrams-Maartens I, van Wering H, Hurkmans P, Stapelbroek J, Sauve I, Wessels M, Teklenburg-Roord S, Pruijsen-Nienhuis JM, Theuns-Valks SDM, Plomp TC, Bunkers C, Keszthelyi D, Benninga MA, Vlieger AM. Peppermint Oil and Sweets in Pediatric Irritable Bowel Syndrome and Functional Abdominal Pain: A Randomized Trial. Clin Gastroenterol Hepatol. 2026 Aug;24(8):2286-2296. doi: 10.1016/j.cgh.2026.01.014. Epub 2026 Jan 27.
PubMed 41610933
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
- ClinicalTrials.gov ID
- NCT05799053
- Acronym / sponsor ID
- MINT / NL78304.100.21
- Conditions
- Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Child, Adolescent, Therapeutics, Adverse Drug Event
- Keywords
- Peppermint oil, Irritable Bowel Syndrome, Functional Abdominal Pain - Not Otherwise Specified, Paediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Apr 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients are randomized in three groups: 1) peppermint oil capsules, 2) placebo), peppermint sweets
| Arm | Type | Receives |
|---|---|---|
| Peppermint oil capsules (Tempocol®) | Experimental | Drug: Small intestinal release peppermint oilEnteric-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 |
| Placebo | Placebo comparator | Drug: PlaceboCapsule 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 |
| Peppermint sweets (Wilhelmina®) | Experimental | Drug: Peppermint sweetsWilhelmina® 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 |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Small intestinal release peppermint oilAlso: Peppermint oil, Menthae piperitae aetheroleum, Tempocol®, A03AX15Tempocol®, 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 oil capsules (Tempocol®) |
| Peppermint sweetsAlso: 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. | Drug | Peppermint sweets (Wilhelmina®) |
| PlaceboCapsule containing microcrystalline cellulose | Drug | Placebo |
Primary outcome
Abdominal pain intensity response rate after 8 weeks of treatment
Time frame: 8 weeks
The proportion of patients with ≥ 30% reduction of their abdominal pain intensity after 8 weeks of therapy compared to baseline. This will be assessed by a smartphone diary app, on which patients record daily at the end of the day the intensity of their abdominal pain during a period of 7 consecutive days using a 10 point Likert scale/Wong-Baker faces scale. A score of 0 correlates with no pain and a score of 10 correlates with the worst imaginable pain. The intensity scores of 7 days will be summed up.
17 secondary outcomes
Change in pain duration
Time frame: 4 weeks, 8 weeks, 12 weeks
Change in pain frequency
Time frame: 4 weeks, 8 weeks, 12 weeks
Change in abdominal pain intensity
Time frame: 4 weeks, 8 weeks, 12 weeks
Change in Quality of Life
Time frame: 8 weeks
Change in depression and anxiety score
Time frame: 8 weeks
School absences during the treatment
Time frame: 4 weeks, 8 weeks, 12 weeks
Use of pain rescue medication during the treatment
Time frame: 4 weeks, 8 weeks, 12 weeks
Expectancy of treatment
Time frame: 0 weeks
Expectancy of treatment
Time frame: 0 weeks
Change in defecation pattern
Time frame: 4 weeks, 8 weeks, 12 weeks
Adequate relief
Time frame: 4 weeks, 8 weeks, 12 weeks
Health status
Time frame: 8 weeks
Costs
Time frame: 8 weeks, 12 weeks
Safety of peppermint oil
Time frame: 4 weeks, 8 weeks, 12 weeks
Ease of use of peppermint oil capsules, placebo capsules or peppermint sweets
Time frame: 8 weeks
Taste of peppermint oil capsules, placebo capsules or peppermint sweets
Time frame: 8 weeks
Placebo genes
Time frame: 0 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41610933Vermeijden NK, van der Feen C, Groeneweg M, Hummel T, Zagers D, Bertrams-Maartens I, van Wering H, Hurkmans P, Stapelbroek J, Sauve I, Wessels M, Teklenburg-Roord S, Pruijsen-Nienhuis JM, Theuns-Valks SDM, Plomp TC, Bunkers C, Keszthelyi D, Benninga MA, Vlieger AM. Peppermint Oil and Sweets in Pediatric Irritable Bowel Syndrome and Functional Abdominal Pain: A Randomized Trial. Clin Gastroenterol Hepatol. 2026 Aug;24(8):2286-2296. doi: 10.1016/j.cgh.2026.01.014. Epub 2026 Jan 27.
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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. This study is not recruiting at the moment.
Arine Vlieger, MD, PhD principal investigator
St. Antonius Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Small intestinal release peppermint oil and Peppermint sweets in people with Irritable Bowel Syndrome and Functional Abdominal Pain Syndrome, run by St. Antonius Hospital at 3 sites in Netherlands.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abdominal pain intensity response rate after 8 weeks of treatment (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 NCT05799053, which also lists 1 linked publication.
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 30 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.