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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT01934257
Eligibility Criteria:
Inclusion Criteria:
* Subject is between 2 and 12 weeks of age
* Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet
* Subject has never switched to any lactose free formula
* The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age
* The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea
* Signed Informed Consent
Exclusion Criteria:
* Subject is in daycare for more than 4 hours per day (20 hours per week)
* Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding
* The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment
* Subject has acute infectious diarrhea or any other intercurrent illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
12 Weeks
Study:
NCT01934257
Study Brief:
Protocol Section:
NCT01934257