The Trial of a New Infant Formula in Healthy Term Chinese Infants

Safety and Efficacy of Infant Formula Containing a Specific Blend of Six Human Milk Oligosaccharides: A Double-blind, Randomized, Controlled Trial

The aim of this randomized, controlled, multi-center, double-blind study of healthy term infants is to test the safety and efficacy of a new infant formula with a specific blend of six human milk oligosaccharides. The primary objective of the trial is to demonstrate the safety of the new infant formula supplemented by comparing the growth of infants randomized to the experimental formula versus the control formula from enrollment to the age of 4 months. The study has an interventional phase up to 6 months of age including 5 visits followed by an observational phase up to 12 months of age for a subgroup of the first 50 breastfed infants and the first 110 formula-fed infants including 2 additional visits.

Inclusion Criteria:

1. Evidence of personally signed and dated informed consent indicating that the infant's both parents/legally acceptable representative(s) (LAR(s)), as per local regulation, have been informed of all pertinent aspects of the study.
2. Parents/LAR(s) of infants have reached the legal age of majority in China.
3. Parents/LAR(s) of infants are willing and able to comply with scheduled visits, and the requirements of the study protocol and can be contacted directly by telephone throughout the study.
4. At enrollment visit, infant post-natal age is ≤14 days (date of birth = day 0)
5. Healthy term infant (≥37 weeks of gestation).
6. Infant birth weight was ≥2500g and ≤4000g.
7. For formula-fed groups, infant is exclusively consuming and tolerating a cow' s milk infant formula since at least 3 days prior to enrollment. Its parents/LAR(s) have independently elected not to breastfeed.
8. For the breastfed REFERENCE group, infant has been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established), and its parents/LAR(s) have made the decision to continue exclusively breastfeeding until at least 4 months of age.

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:

   • Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
   • Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
   • Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infant inappropriate for entry into the study. Of note, infants who are normally healthy but at the time of enrollment suffering from acute illness in a minor condition which are common in infancy and do not require some of the exclusionary medication mentioned below can be enrolled.

3. Presently receiving or have received prior to enrollment any medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion.

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