Not Yet RecruitingNot Applicable

Efficacy of a Dietary Supplement in Infants

172 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range19 Weeks – 21 Weeks

SexALL

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Inclusion criteria

✓. 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
✓. Parent(s) / LAR(s) can be contacted directly by telephone throughout the study
✓. Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer
✓. Parent(s) / LAR(s) of formula-fed infants (either exclusively or mixed-fed) must have previously and independently decided to use formula and their infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment
✓. Infant must be healthy based on medical history and physical examination

Exclusion criteria

✕. 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
✕. Infants who have a medical condition or medical 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)
✕. Immunocompromised infants and those who have a central venous catheter
✕. History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy.
✕. Known or suspected allergy to milk (including lactose) or soy

What they're measuring

Probiotic abundance

Timeframe: At 5 months (V4) of intervention

Trial details

NCT IDNCT07341477

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Renette Foo

+6568905709 shufenrenette.foo@rd.nestle.com

View on ClinicalTrials.gov More Healthy Infants trials