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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT02518295
Eligibility Criteria:
Inclusion Criteria:
1. HBT\> delta 20ppm (compared with the baseline value) measured at screening visit before challenge tests
2. Having signed the informed consent or having provide his/her legal representative's informed consent
Exclusion Criteria:
1. Known Food allergy
2. Any obstructive (COPD, asthma…) or restrictive respiratory syndrome that may impact breath test measurements
3. Any medically relevant malabsorption syndrome
4. Any medically relevant chronic gut motility disorder other than Irritable Bowel Syndrome (IBS), assessed with Rome III questionnaire
5. Ongoing therapy with drugs known to affect gut motility
6. Any general antibiotherapy taken during or within 4 weeks of study onset
7. Use of lactase pill (eg. Lacdigest®), as well as yoghurt and probiotics, for at least 2 days prior to Visit 0b
8. Subject who cannot be expected to comply with the study procedures
9. Currently participating or having participated in another clinical trial during last 8 weeks prior to the beginning of this study.
10. To be a close collaborator to the Investigators, either in terms of Family relationship and/or professional relationship
11. Pregnancy, based on anamnesis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02518295
Study Brief:
Protocol Section:
NCT02518295