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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06123234
Eligibility Criteria:
Inclusion Criteria:
* Subjects presenting symptoms of IBS according to Rome IV criteria.
* Presence of functional disorders according to assessment questionnaire with a score of 2 or more.
* Age between 3 and 17 years and 11 months.
* Willingness of the subject/parent to participate in the study.
* Willingness of the subject/parent to complete the questionnaire.
* Willingness of subject/parent to use only the product to be tested during the duration of the study.
* Willingness of the subject/parent not to use similar products during the duration of the study.
* Parent's signature of informed consent.
Exclusion Criteria:
* Subjects who do not meet the inclusion criteria.
* Subjects considered unfit by the referring physician.
* Subjects with suspected or confirmed sensitivity to one or more components of the product.
* Subjects with psychiatric comorbidities.
* Subjects with serious illnesses.
* Subjects with differential diagnoses (functional dyspepsia, coeliac disease, IBD, food intolerances, individual hypersensitivities).
* Subjects undergoing ongoing pharmacological treatment, inherent to the disease (e.g. spasmolytics etc.).
* Subjects who have recently (two weeks or less) undergone antibiotic therapy
* Subjects with other concomitant diseases (immune, infectious, respiratory or gastro-intestinal).
* Subjects with growth restriction.
* Subjects with congenital malformations.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT06123234
Study Brief:
Protocol Section:
NCT06123234