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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT06646458
Eligibility Criteria:
Inclusion Criteria:
* • Age 50-70 years (bounds included)
* Body Mass Index (BMI) between 18.5 (bound included) and 30 (bound excluded) kg/m2.
* Ability to comply with the protocol and assessment window:
* Product intake according to instructions.
* Willing to collect, store, deliver stool sample according to instructions.
• Willing to adhere to instructions and restrictions during entire study period\*:
* No probiotic supplementations or products supplemented with probiotics.
* No dietary fiber supplements.
* No medications may modify gastrointestinal function.
* Fluency in speaking, reading and writing in mandarin.
* Capability of the subject to install and use the secure study platform on the smartphone during entire study period.
* Written informed consent. \*Overruled in case of medical needs.
Exclusion Criteria:
* • Known / Existing gastrointestinal diseases or disorders diagnosed by a physician that may interfere with study.
* Known / Existing milk protein allergies, lactose intolerance or other allergies to product ingredients.
* Known / Existing immune diseases or disorders diagnosed by a physician that may interfere with study.
* Use of any medication may modify gastrointestinal function: tricyclic antidepressants, SSRIs/antidepressants, opioids, ACE inhibitor, bate sympathomimetics, systemic antibiotics, intestinal antiseptics, anti-inflammatory medicines (including nonsteroidal anti-inflammatory drugs \[NSAIDs\] and aspirin), anti-histamines, steroids, corticosteroids, laxatives, anti-diarrhoea medication, prokinetics/dopamine-antagonists, metformin, statins, or any other stomach medication (including proton pump inhibitor \[PPIs\], antiacids, and antihistamine2 blockers) within 8 weeks prior to enrolment.
* Consumption of probiotic supplementations or products supplemented with probiotics within 4 weeks prior to enrolment.
* Subject following a special diet, including but not limited to vegan diet, ketogenic diet, low fiber diet, thickening diet etc.
* Incapability to comply with protocol as per the judgement of the investigator.
* Participation in any other studies involving investigational or marketed products concomitantly or 2 weeks prior to enrolment.
* Employees and/or children/family member or relatives of employees of Danone or the participating site.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT06646458
Study Brief:
Protocol Section:
NCT06646458