The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth

Assessing the Impact of a Novel Infant Formula on Immunity, Gut Health and Safety: A Multicenter, Double-blind, Randomized, Controlled Trial

The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.

Inclusion Criteria:

1. At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
2. Healthy term infant (≥ 37 weeks of gestation).
3. Infants birth weight ≥ 2500 and ≤ 4500 g.
4. For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
5. For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
6. Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
7. Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.

Exclusion Criteria:

1. Conditions requiring infant feedings other than those specified in the protocol.

2. Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

   1. Evidence of major congenital malformation (e.g., cleft palate, extremity malformation)
   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
   3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.

3. Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:

   1. Fat digestion, absorption, and/or metabolism (e.g. pancreatic enzymes);
   2. Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
   3. Growth (e.g., insulin or growth hormone);
   4. Gastric acid secretion.

4. Currently participating or having participated in another interventional clinical trial since birth.