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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT06312059
Eligibility Criteria:
Inclusion Criteria:
1. Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator
2. Infants with a birth weight of \>2500 g to \<4500 g
3. Infants ≤11 days of age at enrollment; birth constitutes Day 0
4. Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study
Exclusion Criteria:
A participant who meets any of the following criteria will be excluded from participation in the study:
1. Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)
2. Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth
3. Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development
4. Infant that has received oral or parenteral antibiotics prior to enrollment
5. Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial:
1. Solid foods and juices
2. Vitamins and/mineral supplements, as the study product provided is nutritionally complete
3. Pre- and probiotics
6. Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)
7. Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
14 Days
Study:
NCT06312059
Study Brief:
Protocol Section:
NCT06312059