Back to resultsPeppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study (MINT)
Primary Purpose
Irritable Bowel Syndrome, Functional Abdominal Pain Syndrome, Child
Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Small intestinal release peppermint oil
Peppermint sweets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Peppermint oil, Irritable Bowel Syndrome, Functional Abdominal Pain - Not Otherwise Specified, Paediatrics
Eligibility Criteria
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
Sites / Locations
- De KinderKliniekRecruiting
- Amphia HospitalRecruiting
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Peppermint oil capsules (Tempocol®)
Placebo
Peppermint sweets (Wilhelmina®)
Arm Description
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
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Change in Quality of Life
Change in quality of live will be measured with the PedsQL after 8 weeks of therapy compared to baseline
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
School absences during the treatment
Hours of school absence in the previous week are measured.
Use of pain rescue medication during the treatment
Use of pain rescue medication like paracetamol or NSAIDs
Expectancy of treatment
expectations of both parents separately of the treatment on a scale of 0 (no improvement) to 10 (very much improved)
Expectancy of treatment
the child's expectations of the treatment on a scale of 0 (no improvement) to 10 (very much improved)
Change in defecation pattern
Change in defecation pattern is recorded as the daily stool frequency and consistency according to the Bristol Stool Scale
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)
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
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
Safety of peppermint oil
incidence of adverse events will be reported by the participants
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05799053
Brief Title
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
Acronym
MINT
Official Title
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized in three groups: 1) peppermint oil capsules, 2) placebo), peppermint sweets
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Peppermint oil capsules and placebo are double blinded, peppermint sweets are open-label
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peppermint oil capsules (Tempocol®)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Peppermint sweets (Wilhelmina®)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Small intestinal release peppermint oil
Other Intervention Name(s)
Peppermint oil, Menthae piperitae aetheroleum, Tempocol®, A03AX15
Intervention Description
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
Intervention Name(s)
Peppermint sweets
Other Intervention Name(s)
Wilhelmina®
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Capsule containing microcrystalline cellulose
Primary Outcome Measure Information:
Title
Abdominal pain intensity response rate after 8 weeks of treatment
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in pain duration
Description
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
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Change in pain frequency
Description
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
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Change in abdominal pain intensity
Description
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
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Change in Quality of Life
Description
Change in quality of live will be measured with the PedsQL after 8 weeks of therapy compared to baseline
Time Frame
8 weeks
Title
Change in depression and anxiety score
Description
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
Time Frame
8 weeks
Title
School absences during the treatment
Description
Hours of school absence in the previous week are measured.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Use of pain rescue medication during the treatment
Description
Use of pain rescue medication like paracetamol or NSAIDs
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Expectancy of treatment
Description
expectations of both parents separately of the treatment on a scale of 0 (no improvement) to 10 (very much improved)
Time Frame
0 weeks
Title
Expectancy of treatment
Description
the child's expectations of the treatment on a scale of 0 (no improvement) to 10 (very much improved)
Time Frame
0 weeks
Title
Change in defecation pattern
Description
Change in defecation pattern is recorded as the daily stool frequency and consistency according to the Bristol Stool Scale
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Adequate relief
Description
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)
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Health status
Description
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
Time Frame
8 weeks
Title
Costs
Description
iMCQ and the iPCQ will be used to measure the direct and indirect costs due to health care utilization and work absenteeism by parents
Time Frame
8 weeks, 12 weeks
Title
Safety of peppermint oil
Description
incidence of adverse events will be reported by the participants
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Ease of use of peppermint oil capsules, placebo capsules or peppermint sweets
Description
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.
Time Frame
8 weeks
Title
Taste of peppermint oil capsules, placebo capsules or peppermint sweets
Description
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.
Time Frame
8 weeks
Title
Placebo genes
Description
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.
Time Frame
0 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Vermeijden, MD
Phone
(+31) 020-566 2906
Email
k.vermeijden@antoniusziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arine Vlieger, MD, PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
De KinderKliniek
City
Almere
State/Province
Flevoland
ZIP/Postal Code
1315 RC
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Benninga, MD, PhD
Phone
036 763 0030
Email
m.a.benninga@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Marc Benninga, MD, PhD
Facility Name
Amphia Hospital
City
Breda
State/Province
Noord-Brabant
ZIP/Postal Code
4818 CK
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert van Wering, MD,PhD
Phone
076 595 5000
Email
HvanWering@amphia.nl
First Name & Middle Initial & Last Name & Degree
Herbert van Wering, MD, PhD
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Benninga, MD, PhD
Phone
020 566 9111
Email
m.a.benninga@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Marc Benninga, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Peppermint Oil for the Treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children: the MINT Study
We'll reach out to this number within 24 hrs