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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00653705
Eligibility Criteria:
Inclusion Criteria:
* An informed consent has been signed by the parents.
* The child is at least one year old and has not had his 4th birthday at the beginning of the study
* The child is healthy.
* The child attends child care center at least 5 days a week, \> 4 hours per day.
Exclusion Criteria:
* Was born preterm.
* Had a birth weight \<2,500 g.
* Has congenital anomalies.
* Has a structural abnormality of the digestive tract or previous significant gastrointestinal surgery.
* Has chronic disease or malignancy.
* Has a serious, unstable medical condition.
* Is Failure to Thrive (FTT) (\<5th percentile of ideal body weight).
* Has an allergy or atopic disease.
* Has an allergy or intolerance to milk/dairy products.
* Has an established diagnosis of lactase deficiency.
* Is predisposed to infection (i.e., compromised immune system, HIV-AIDS, active bacterial disease, under steroid treatment).
* Received antibiotic treatment or intentionally consumes probiotic products during the preceding 4 weeks. (If the subject was on antibiotics before the beginning of the study or probiotics, a washout period of 2 weeks is required.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
48 Months
Study:
NCT00653705
Study Brief:
Protocol Section:
NCT00653705