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:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT03225261
Eligibility Criteria:
Inclusion Criteria:
* Patients with IBS
* Calprotectin levels 15-150 µg/g feces
* Age 18-70 years
* BMI \< 35 kg/m2
Exclusion Criteria:
* Comorbidities that may influence gut microbiota composition or which might limit participation in or completion of the study protocol (to be decided by the principle investigator)
* Abdominal surgery interfering with gastrointestinal function (to be decided by the principle investigator)
* Use of immunosuppressive drugs within 3 months before study period
* Use of other medication interfering with endpoints
* Changes in medication that may significantly affect the study outcome according to the investigator's judgment within 1 month prior to the study
* Changes in clinical activity scores within 3 weeks prior to 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
* Use of dietary supplements containing antioxidants, minerals and vitamins
* Excessive intake of foods with a high polyphenol concentration
* Use of antibiotics within 3 months prior to the start of study
* Use of pre-or probiotics within 1 month prior to the study
* Use of oral corticosteroids within 1 month prior to the study
* Blood donation within 1 month prior to the study
* Known pregnancy or lactation.
* Excessive drinking (\>20 alcoholic consumptions per week)
* History of any side effects towards the intake of flavonoids or citrus fruits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03225261
Study Brief:
Protocol Section:
NCT03225261