NCT03513744

Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Jennewein Biotechnologie GmbH · Industry
• Sex: All
• Age: 1 Day – 13 Days
• Healthy volunteers: Accepted

Summary

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

Detailed description

The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well. As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.

Conditions

• Infant Nutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	human milk oligosaccharides	mixture of five different human milk oligosaccharides

Timeline

• Start date: 2018-11-19
• Primary completion: 2021-03-03
• Completion: 2021-04-05
• First posted: 2018-05-02
• Last updated: 2023-10-16

Locations

9 sites across 3 countries: Germany, Italy, Spain