The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.

Primary objective:

To compare the growth measurements of the infants fed with the a2 infant formula with those fed with conventional A1/A2 infant formula during the study period.

Secondary objectives:

To compare the two study groups in

1. Dermatitis quality of life
2. Formula tolerability and acceptability
3. All medically confirmed adverse events

The study included four visits at day 0 (baseline), day 14, day 28 and day 56. Information of efficacy outcomes were collected at each visit. Subject diary was used to record tolerance data and daily formula feeding amount during the study. The parents of the participants were also required evaluate their satisfaction with the study formula at the last visit.

Inclusion Criteria:

• Healthy and term infants (37-42 weeks gestation);
• Birth weight between 2500g and 4500g;
• 60-120 days of age after birth;
• Mixed-fed: Infants who were fed with a mixture of formula and human milk, and received daily formula consumption of more than 400ml;
• Signed informed consent obtained form the guardian(s) of the infants;
• Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey.

Exclusion Criteria:

• Congenital anomaly or hereditary/chronic/congenital diseases that could interfere with the study product evaluations;
• Evidence of feeding difficulties or intolerance/allergy to cow's milk;
• Conditions requiring infant feedings other than those specified in the protocol;
• Significant systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastrointestinal, or other) or parental refusal to participate;
• Acute infection or gastroenteritis at the time of enrollment;
• Participation in other clinical trials at the time of the study;
• Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.