Phase
Condition
N/ATreatment
Experimental 1st age starter infant formula
Control 1st age starter infant formula
Experimental1st age starter infant formula
Clinical Study ID
Ages 14-35 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Evidence of personally signed and dated informed consent document indicating that atleast one of the infant's parent(s)/LAR(s), as per local regulation, have beeninformed of all pertinent aspects of the study.
Infants whose parent(s)/LAR(s) have reached the legal age of majority in thecountries where the study is conducted.
Able to temporarily store stool samples in a household freezer.
Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits,and the requirements of the study protocol.
Infants whose parent(s)/LAR(s) are able to be contacted directly by telephonethroughout the study.
Infants must meet all of the following inclusion criteria to be eligible forenrollment into the study:
Healthy term infant (≥37 weeks of gestation).
At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date ofbirth = day 0)
Birth weight ≥ 2500g and ≤ 4500g.
For formula-fed groups, infants must be exclusively consuming and tolerating acow's milk infant formula at time of enrollment and their parent(s)/LAR(s) musthave independently elected, before enrollment, not to breastfeed.
For the breastfed group, infants must have been exclusively consumingbreastmilk since birth (small amounts of other feedings allowed during thefirst three days of life before breastfeeding is well-established), and theirparent(s)/LAR(s) must have made the decision to continue exclusivelybreastfeeding until at least 4 months of age.
Exclusion
Exclusion Criteria:
Infants with conditions requiring infant feedings other than those specified in theprotocol.
Infants who have a medical condition or history that could increase the riskassociated with study participation or interfere with the interpretation of studyresults, including:
Evidence of major congenital malformations (e.g., cleft palate, extremitymalformation).
Suspected or documented systemic or congenital infections (e.g., humanimmunodeficiency virus, cytomegalovirus, syphilis).
Previous or ongoing severe medical or laboratory abnormality (acute or chronic)which, in the judgment of the investigator, would make the infant inappropriatefor entry into the study. Of note, children who are normally healthy but at thetime of enrolment suffering from acute illness in a minor condition which arecommon in childhood and do not require some of the exclusionary medicationmentioned below can be enrolled.
Infants who are presently receiving or have received prior to enrolment any of thefollowing: medication(s) or supplement(s) which are known or suspected to affect thefollowing: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes);stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerinsuppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);growth (e.g., insulin or growth hormone); gastric acid secretion.
Currently participating or having participated in another interventional clinicaltrial since birth.
Study Design
Connect with a study center
Asian Hospital and Medical Center
Manila,
PhilippinesSite Not Available
University of Perpetual Help DALTA Medical Center
Manila,
PhilippinesSite Not Available
University of the East Ramon Magsaysay Memorial Medical Center
Manila,
PhilippinesSite Not Available
Asian Hospital and Medical Center
Manila 1701668,
PhilippinesSite Not Available
University of Perpetual Help DALTA Medical Center
Manila 1701668,
PhilippinesSite Not Available
University of the East Ramon Magsaysay Memorial Medical Center
Manila 1701668,
PhilippinesSite Not Available

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