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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT04256551
Eligibility Criteria:
Inclusion Criteria:
* IBS-SSS score ≥ 175 (moderate to severe IBS)
* meet the Rome IV criteria for IBS of any type including those with IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), IBS mixed typed (IBS-M), or IBS unsubtyped (IBS-U), and had symptoms for the past 3 months or greater
* own an I-phone
* have not used a dietary application or elimination diet for IBS in the past 6 months
* must be willing to participate in the low FODMAP diet intervention over a 4-week period with a monitoring period of 2-weeks
* agree to complete online questionnaires as frequently as once per week from study start.
Exclusion Criteria:
* individuals with food allergies (not food intolerances)
* smokers
* those with history of chronic disease (other than gastrointestinal dysfunction)
* nutrition student or professional
* prescription medication is permitted unless the medication is to treat IBS (which includes steroids).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04256551
Study Brief:
Protocol Section:
NCT04256551