About this trial
This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age
Eligibility criteria
Qualifiers
Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR])
Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
Parent(s) / LAR(s) must understand the informed consent form and other study documents
Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol
Disqualifiers
Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
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 antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)
Trial design
Treatments tested in this trial
- Probiotic dietary supplement
- Placebo dietary supplement
Treatment groups
Locations
Sponsors and collaborators
Société des Produits Nestlé (SPN)
Lead sponsor
University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines
Collaborator
Asian Hospital and Medical Center, Muntinlupa, Philippines
Collaborator