NCT04880083

Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein

Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein: A Single-arm, Open-label, Prospective Interventional Study Including a Breastfed Reference Group

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 3 Days – 28 Days
• Healthy volunteers: Accepted

Summary

This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants as reference group. Approximately 120 male and female infants (60 per group) who are 3-28 days old and are exclusively or predominately formula-feeding or breastfeeding will be enrolled.

Detailed description

Breastmilk contains an abundance of structurally diverse compounds having important physiologic roles. These include glycoproteins which are biologically active and involved in infant gut, immune and brain development (Jiang and Lönnerdal 2016). The overall purpose of this study is to study the effectiveness of a term infant formula rich in glycoprotein (formula-fed group) on gastrointestinal tolerance, and gastrointestinal health in healthy term infants compared to a breast-fed reference group. We hypothesize that there will be comparable gastrointestinal tolerance in formula-fed and breast-fed and that fecal bifidobacteria changes in early infancy in the formula-fed group are similar to that of breast-fed infants.

Conditions

• Digestion
• Gut Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Commercially Available Starter Infant Formula	Study formula is provided in powder form and will be administered orally, ad libitum, via an infant feeding bottle and the volume of formula offered to the infant will be guided by the recommended feeding table for the age group or by physician recommendation. The amount consumed by the infant will vary by each infant's weight and appetite.

Timeline

• Start date: 2021-07-09
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2021-05-10
• Last updated: 2025-07-02

Locations

1 site across 1 country: China