Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-003690-65
    Sponsor's Protocol Code Number:78304
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-21
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003690-65
    A.3Full title of the trial
    Peppermint Oil for the treatment of Irritable Bowel Syndrome or Functional Abdominal Pain in Children:
    the MINT study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Peppermint Oil Capsules versus placebo capsules versus regular mints for the treatment of abdominal pain in children with Irritable Bowel Syndrome or Functional Abdominal Pain: the MINT study
    A.3.2Name or abbreviated title of the trial where available
    the MINT trial
    A.4.1Sponsor's protocol code number78304
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSt Antonius Hospital
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPrins Bernhard Cultuur Fonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Antonius Hospital Nieuwegein
    B.5.2Functional name of contact pointK. Vermeijden
    B.5.3 Address:
    B.5.3.1Street AddressKoekoekslaan 1
    B.5.3.2Town/ cityNieuwegein
    B.5.3.3Post code3435 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31883203000
    B.5.6E-mailmint@antoniusziekenhuis.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tempocol
    D.2.1.1.2Name of the Marketing Authorisation holderWill-Pharma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTempocol
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Irritable Bowel syndrome
    Functional Abdominal Pain Not otherwise specified
    E.1.1.1Medical condition in easily understood language
    Chronic abdominal pain due to irritable bowels
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study's primary objective is to investigate the effectiveness of peppermint oil capsules compared to placebo capsules on abdominal pain reduction in children with irritable bowel syndrome or functional abdominal pain- not otherwise specified.
    E.2.2Secondary objectives of the trial
    Secondary aims are to study the effect of peppermint oil capsules on other disease-related outcomes. These are recently defined outcome measures for trials in children with chronic abdominal pain: degree of reduction in pain frequency and pain intensity, percentage of patients with adequate improvement of complaints, hours of absenteeism, quality of life, feelings of anxiety & depression, bowel habits, taste, ease of use and side effects of the treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Children aged between 8 and 18 years
    • Diagnosis of IBS or FAP-NOS according to the Rome IV criteria
    • Exclusion of underlying organic disorders 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 ≥2 on the Wong Baker Faces Pain Scale (This is a validated pain scale to measure pain intensity).36
    • Informed Consent by both parents and by children aged ≥ 12 years. No informed consent from parents is necessary for children >16 years.
    E.4Principal exclusion criteria
    • Current treatment by another health care professional for abdominal symptoms
    • Previous use of peppermint oil for 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of children showing > 30% reduction in abdominal pain intensity after 8 weeks of treatment from baseline. Abdominal pain intensity will be scored with the Wong-Baker faces scale, during 7 consecutive days, using a smartphone abdominal pain app.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the treatment, 8 weeks (T2) after baseline (T0). Other time points in this study are halfway treatment (T1 = 4 weeks) and after 4 weeks of follow-up (T3=12 weeks)
    E.5.2Secondary end point(s)
    • Change in pain duration: abdominal pain duration will be scored in minutes of abdominal pain per day during 7 consecutive days, using the smartphone abdominal pain app at T0, T1, T2 and T3.

    • Change in pain frequency: abdominal pain frequency will be scored as the average amount of days with pain during 7 consecutive days, using the smartphone abdominal pain app at T0, T1, T2 and T3.

    • Change in abdominal pain intensity: abdominal pain intensity will be scored during a period of 7 consecutive days using a 10-point Wong-Baker faces scale, using daily the smartphone abdominal pain app at T0, T1, T2 and T3.

    • Change in Quality of Life: Quality of life is measured by the Dutch version of the Paediatric Quality of Life Inventory questionnaire (PedsQL 4.0). It will be measured at baseline (T0) and after 8 weeks (T2, end of treatment).
    • Change in depression and anxiety score: depression and anxiety scores are measured by the Revised Anxiety and Depression Scale-short version (RCADS-25) at T0 and T2.

    • School absences during the treatment: hours of school absence in the previous are measured by a self-designed questionnaire at T0, T1, T2, and T3.

    • Use of pain rescue medication during the treatment (like paracetamol or NSAIDs): assessed by the smart phone app, on which patients can record the use of rescue pain medication. It will be measured at T0, T1, T2, and T3.

    • Expectancy of the treatment: expectations of both parents separately, and the child of the treatment on a scale of 0 (no improvement) to 10 (very much improved) are measured by a self-designed questionnaire at start of baseline period.

    • Change in defecation pattern: change in defecation pattern is scored using the smart phone app, on which patients can record daily stool frequency and consistency according to the Bristol Stool Scale. This will be measured at T0, T1, T2 and T3.

    • Adequate relief: patients and parents will be asked whether they/their child has adequate relief of IBS/FAP-NOS symptoms using a single question ("Did you/your child 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). This instrument will be measured at 4 weeks (T1), at the end of treatment (T2), and at 12 weeks (4-week follow-up (T3).

    • Health status: the Health Utility Index Mark 3 (HUI-3) will be applied as a multi-attribute utility measure of health status and will be used in the cost-effectiveness and cost-utility analysis. It is suitable for assessing children, but because children may be too young to provide reliable and valid information about their own health status, proxy measurements will be taken from parents. The health utilities derived from the HUI-3 have been anchored with 1 indicating perfect health and 0 indicating death. Quality adjusted life years (QALY) will be calculated by taking the sum of the utility of health states over time by the time in between successive measurements. It will be measured at start of the baseline period, and at 8 weeks.

    • Costs: the Dutch Health and Labour Questionnaire (HLQ) will be adapted to the study setting to measure the direct and indirect costs of health care utilization, work absenteeism by parents, and school absenteeism by children. It will be measured at T0 and T2.

    • Safety of peppermint oil use: incidence of adverse events will be reported by the participants from the time of informed consent until the 4 weeks follow-up using open questions: “did you experience other symptoms than usual, that may have been caused by the study medication?

    • Taste and ease of use of peppermint oil capsules. Taste of capsules will be scored after 8 weeks using a single question: did you like the taste of the pills: not at all/ not so much/ it was okay/ it was nice/ it was very nice. Ease of use of capsules will also be scored after 8 weeks using a single question: how easy were the pills to use and swallow? Very easy/ easy/ reasonable/ difficult/ very difficult.

    • Other study parameters are subject characteristics like age, sex, previous treatments, duration of symptoms before start study and family history.

    • Association between SNP’s in placebo genes and response to peppermint oil capsules, placebo capsules and peppermints will be determined by collecting DNA through a saliva swab. DNA samples will be genotyped using the Infinium Global Screening Array. Variants previously identified to be associated with the placebo effect will be extracted from the imputed data and analyzed in a candidate gene approach.
    E.5.2.1Timepoint(s) of evaluation of this end point
    time points are T0 = baseline; T1 = 4 weeks after starting treatment; T2 = 8 weeks after starting treatment/ end of treatment period; T3= 4 weeks of follow-up after end of treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    a third group will receive regular mint sweets (a plausible placebo)
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 240
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 120
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 120
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 16:37:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA