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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01782456
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 3 and ≤ 10 years of age
* Healthy and not suffering from any physical disability.
* Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
* Consumption of 2 servings/day of the investigational product for 7 consecutive days
* Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
* Agreement to not consume a nutritional product that is not study product during the study period
Exclusion Criteria:
* History of an acute or chronic condition that may affect feeding habits or nutritional status
* Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
* Clinically significant nutritional deficiency requiring specific treatment
* Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
* History of constipation
* Allergy or intolerance to any ingredient in the study product
* Gastrointestinal infection or acute diarrhea at the time of study start
* Hepatitis B or C, or HIV, or malignancy
* Congenital cardiac defects
* Antibiotic therapy within last 2 weeks of start of study
* Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
10 Years
Study:
NCT01782456
Study Brief:
Protocol Section:
NCT01782456