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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT01724203
Eligibility Criteria:
Inclusion Criteria:
* Age 6 to 12 months.
* Known vaccination history.
* Ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects.
* Parental or legal guardian's consent to the study and willing to comply with study procedures.
Exclusion Criteria:
* Symptoms of any infection at screening.
* History of ≥5 infections in the previous 2 months.
* Lactose intolerance or unable to drink milk.
* Leukopenia or leukocytosis.
* Immunodeficient or use of immunosuppressive drugs.
* Use of antibiotic and anti-inflammatory medications within the last 2 weeks.
* Use of products containing prebiotics or probiotics within the last 2 weeks.
* Use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks.
* Hepatitis B or C.
* Medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator.
* Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
* Participation in another study with any investigational product within 3 months of screening.
* Any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Months
Study:
NCT01724203
Study Brief:
Protocol Section:
NCT01724203