NCT03722550

Second Generation Human Milk Oligosaccharides Blend Study

Growth, Safety and Efficacy of a Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides: a Double-blind, Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 789 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 7 Days – 21 Days
• Healthy volunteers: Accepted

Summary

The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs. There will be different groups in the trial: three formula-fed groups and a breastfed group.

Detailed description

These 5 HMOs are identical to the ones found naturally in human milk. They are natural prebiotics (or complex sugars) with potential health benefits. Prebiotics are natural compounds that help the establishment of beneficial gut bacteria (such as bifidobacteria), while preventing bad bacteria from doing harm. Supplementing diets with certain prebiotics has been shown to be well tolerated in adults and infants and to provide potential benefits.Therefore, the trial also aims to understand if consuming HMOs supplemented formulas could strengthen immunity and prevent common illnesses (for example, respiratory illnesses) in infants and toddlers. Furthermore, stool frequency and consistency will be monitored, so as to evaluate digestive tolerance to the formula.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
OTHER	Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides	Study formulas are administered orally, ad libitum, from enrollment until 15 months of age
OTHER	Breast-feeding	Exclusive Breast-feeding up to 4 months of age
OTHER	Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk	Standard Study formulas are administered orally, ad libitum, from enrollment until 15 months of age

Timeline

• Start date: 2018-09-19
• Primary completion: 2021-11-05
• Completion: 2022-01-19
• First posted: 2018-10-29
• Last updated: 2022-02-17

Locations

34 sites across 3 countries: Bulgaria, Hungary, Poland