Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03003260
Eligibility Criteria:
Inclusion Criteria:
* Male
* Female, only when using the contraceptive pill
* Adults, aged 18-65
* IBS, diagnosed according to the Rome III criteria
* More than 3 moments of pain with a vas-score of 4 and higher per week
* Signed informed consent
Exclusion Criteria:
* Use SSRIs, tramadol or tramagetic
* Have a history of intestinal surgery that might interfere with the outcome of the study
* Female patients: currently pregnant or breast-feeding hope to become pregnant during the study, judged by the persons self.
* Female who is not using the contraceptive pill.
* Are an employee and students of the department of Human Nutrition at Wageningen UR, or employee at the MDL department of hospital Gelderse Vallei
* Participate in another research study
* Alcohol use (male more than 14 servings a week, female more than 7 servings a week)
* Cannabis use is from 3 months before until the end of the study not allowed.
* Hypersensitivity to one of the ingredients of the chewing gum
* Drug use (CYP2C19 and CYP3A4) metabolised; medication will be evaluated for this by the principal and medical investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03003260
Study Brief:
Protocol Section:
NCT03003260