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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02550704
Eligibility Criteria:
Inclusion Criteria:
* IBS-Diarrhoea according to Rome III criteria,
* Faecal calprotectin ≤200 µg/g in the last two months
* Effective contraception since 1 month for women in childbearing age
Exclusion Criteria:
* Patients with organic and/or inflammatory digestive disease
* IBS with constipation or alternating
* Treatment such as anti-inflammatory, probiotic in the last three months
* Patient with blood dyscrasia disorder known or identified , anticoagulant or antiplatelet treatments
* Small intestinal bacterial overgrowth (identified by a glucose breath test)
* Hypersensitivity to Normacol
* Severe renal failure
* Anal pathology (anal fissure, hemorrhoidal thrombosis)
* Pregnant or breastfeeding women
* Person with administrative or judicial decision or under legal protection measure
* Patient participating in another trial in the last two weeks
* Diet based in grapes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02550704
Study Brief:
Protocol Section:
NCT02550704