Efficacy of a Dietary Supplement in Infants
ConditionHealthy Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-21
SponsorSociété des Produits Nestlé (SPN)
About this trial
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.
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 including infant blood collection
Disqualifiers
Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
Infants receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment
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)
Trial design
Treatments tested in this trial
- Experimental Group
- Control Group (CG)
Treatment groups
172 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov