Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
Condition: Irritable Bowel Syndrome; Abdominal Pain; Colonic Diseases; Visceral Pain
MeSH terms: Irritable Bowel Syndrome; Colonic Diseases; Abdominal Pain; Visceral Pain
Intervention: Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule); Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)
Intervention description: Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.; Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region.
Intervention MeSH terms: Peppermint oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Peppermint oil; Menthol; Volatile oil; Plant oil; Visceral pain; Abdominal pain; Irritable bowel syndrome (IBS); Colonic disease

Summary:

      This is a pilot study to compare the relative bioavailability between two peppermint oil
      formulations, namely a ileocolonic release peppermint oil and an small intestinal release
      peppermint oil (Tempocol®). This study is conducted as part of a future multicenter
      randomized controlled trial that will assess the therapeutic effect of the new peppermint oil
      formulation in IBS patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Based on medical history and previous examination, no gastrointestinal complaints can
             be defined

          -  Age between 18 and 65 years

          -  BMI between 18 and 25 kg/m2 and a weight of at least 50 kilograms

          -  Women in fertile age (<55 years old) must use contraception or be postmenopausal for
             at least two years

        Exclusion Criteria:

          -  History of severe or chronic cardiovascular, respiratory, urogenital,
             gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose,
             throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional,
             endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory
             assessments which might limit participation in or completion of the study protocol

          -  Use of medication, including vitamin and iron supplementation, except oral
             contraceptives, within 14 days prior to start of the study

          -  Administration of investigational drugs or participation in any scientific
             intervention study which may interfere with this study (to be decided by the principle
             investigator), in the 180 days prior to the study

          -  Major abdominal surgery interfering with gastrointestinal function (uncomplicated
             appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon
             judgment of the principle investigator)

          -  Dieting (for example lactose-free, gluten-free, caloric-restrictive, vegetarian or
             vegan, macrobiotic diet)

          -  Pregnancy, lactation

          -  High alcohol consumption (>15 alcoholic consumptions per week)

          -  Smoking/ Using drugs of abuse

          -  Self-admitted HIV-positive state

          -  Known allergic reaction to peppermint

          -  High intake of caffeine (>8 cups coffee a day)