Growth, Safety and Efficacy of a Probiotic Supplement

This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimental group. The study population, approximately 228, are infants 14 - 21 days of age who are formula-fed and/or breastfed who is aligned with the intended target population for a probiotic supplement. Placebo and probiotic supplements will be mixed with formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants will participate in the trial for approximately 8 weeks.

Inclusion criteria

• Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
• Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
• Infants whose parent(s)/LAR have access to a working freezer.
• Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:

• Healthy term (37-42 weeks of gestation) infant at birth.
• At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
• Birth weight ≥ 2500g and ≤ 4500g.
• Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention.
• Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment.

Exclusion criteria

• Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol.
• Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
• Infants who have a 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).
• History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
• Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study.
• Infants who are presently receiving or have received prior to enrollment probiotic supplements or any of the following: 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 (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
• Currently participating or having participated in another clinical trial since birth.