NCT07341477

Efficacy of a Dietary Supplement in Infants

Microbiome and Health-related Effects of a Dietary Supplement in Infants: a Double-blind, Randomized, Placebo-controlled Nutritional Study.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 19 Weeks – 21 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants, consisting of 2 randomized parallel arms: experimental group (EG) receiving a dietary supplement and a control group (CG) receiving a placebo supplement. The population under investigation is healthy infants aged 5 months +/- 1 week at the time of clinic visit 1. The planned sample size for this study is 172 infants (86 per study group). Each investigational product (EG and CG) will be provided in powder form and packaged in single dose stick packs. The powder will be dissolved in lukewarm formula or body temperature breastmilk and fed orally to the infants using a provided infant feeding beaker. 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 from enrolment until 5 months of intervention. In addition, fecal metabolic biomarkers, gastrointestinal (GI) related outcomes, blood markers of immune health, fecal markers of gut and immune health, bone quality, other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental Group	Dietary supplement in powder form
OTHER	Control Group (CG)	Placebo dietary supplement in powder form

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2026-01-14
• Last updated: 2026-01-14