Status:
COMPLETED
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Irritable Bowel Syndrome
Abdominal Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 (Tempo...
Detailed Description
Rationale: Peppermint oil has shown to be effective in the treatment of IBS symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint oil remains relatively under-us...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02291445
Start Date
March 1 2015
End Date
September 1 2015
Last Update
January 24 2022
Active Locations (1)
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1
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 5800