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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT02016703
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Age 4 to 6 years at Study D1 (day of consumption of the first beverage)
* Body Mass Index ³ 13 kg/m²
* Accustomed to having breakfast
* Having a regular defecation frequency inferior or equal to two per day
* Able to drink 250 mL within 15 minutes
* Toilet-trained / able to use a potty (both at day and night)
* Informed consent of both person entitled to parental rights
* Person entitled to parental rights affiliated to the French social security
Exclusion Criteria:
* Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before D1 of the study
* Participation in any non-invasive clinical trial up to 30 days before D1 of this study, including blood sampling and/ or, intravenous, inhalatory administration of substances
* Having a history of medical or surgical events that may significantly affect the study outcome, such as gastric and digestive diseases
* Any current metabolic or endocrine disease, including diabetes mellitus
* Use of medication, including antibiotics, laxatives and steroids
* Regular gastrointestinal complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
6 Years
Study:
NCT02016703
Study Brief:
Protocol Section:
NCT02016703