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 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT04997057
Eligibility Criteria:
Inclusion Criteria:
* Irritable Bowel Syndrome with constipation (IBS-C) according to Rome IV criteria ;
* IBS-SSS between 175-300 in the last 10 days ;
* Have experienced abdominal pain ≥ 40 according to the IBS-SSS questionnaire (abdominal pain item) during the last 10 days ;
* Whose abdominal pain / discomfort has had a significant impact on daily life during the past 10 days (impact ≥2 on a 5-point likert scale (from 0: no impact to 5: extreme impact) ;
* Ability to understand instructions and complete questionnaires Nurstrial APP.
* Affiliate or beneficiary of a social security ;
* Having given their free, informed and written consent.
Exclusion Criteria:
* CPRu \> 10 mg/l
* Pregnant or breastfeeding woman, woman planning a pregnancy during the study period ;
* Intolerance or proven food allergy ;
* BMI \<18.5 kg / m2 or BMI\> 35 kg / m2 ;
* Diagnosis or known history of IBS-D, IBS-M, or unclassified forms of IBS, or other gastrointestinal pathologies ;
* With current first-line IBS-C treatment or second-line treatment ;
* alternative non pharmacological treatment ;
* Drug treatment affecting visceral sensitivity or intestinal transit ;
* dietary modification (exclusion of FODMAPs, prebiotic) or lifestyle ;
* Excessive smoking or drinking ;
* Having or planning bariatric surgery,
* With known pathologies affecting gut function ;
* With a deviant eating behavior,
* Treated with antibiotics in the 3 months preceding inclusion,
* Under legal protection,
* Already included in a clinical trial,
* With severely impaired physical/psychological health may affect study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04997057
Study Brief:
Protocol Section:
NCT04997057