Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-28
SponsorSociété des Produits Nestlé (SPN)

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

327 Participants
are divided into 3 treatment groups

Locations

This trial has no 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