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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT06413004
Eligibility Criteria:
Inclusion Criteria:
* Patients with IBS diagnosis according to their treating physician (ROME IV).
* Association between intake of food and GI symptoms.
* Witnessed written informed consent prior to any study procedures.
* Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements.
Exclusion Criteria:
* Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes, uncontrolled thyroid disease, heart disease, kidney disease, liver disease, and active malignant disease (not those that were in remission at least 5 years).
* Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility.
* Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test).
* Clinical history of severe allergic reactions.
* Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year.
* Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.
* Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06413004
Study Brief:
Protocol Section:
NCT06413004