Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Dietary Supplement: human milk oligosaccharides

• Registration Number: NCT03513744
• Lead Sponsor: Jennewein Biotechnologie GmbH

Brief 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.

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-02
• Study Start: 2018-11-19
• Primary Completion: 2021-03-03
• Study Completion: 2021-04-05
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Singleton birth
• Full-term infant (37 - 42 weeks of gestational age)
• APGAR score of 9 or 10
• Birth weight 2500 - 4500 g

Exclusion Criteria

• clinically significant condition/ disorder
• Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
• readmission to hospital (except for hyperbilirubinemia)
• allergy to cow's milk
• participation in another study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
infant formula containing five HMOs	human milk oligosaccharides	-

Primary Outcome Measures

Name	Time	Method
assessment of body weight (in grams) of term infants	4 month	growth, assessed by body weight gain, of term infants from enrollment to 4 month of life

Secondary Outcome Measures

Name	Time	Method
assessment of body length (in centimeter) of term infants	4 month	growth, assessed as body length, of term infants from enrollment to 4 month of life
assessment of head circumference (in centimeter) of term infants	4 month	growth, assessed as head circumference, of term infants from enrollment to 4month of life

Trial Locations

Locations (9)

Hospital HM Puerta del Sur; 🇪🇸 Madrid, Spain

Facharzt für Kinder und Jugendmedizin; 🇩🇪 Mannheim, Germany

ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini; 🇮🇹 Brescia, Italy

Klinikum Südstadt Rostock; 🇩🇪 Rostock, Germany

Hospital Universitario Sant Joan de Reus; 🇪🇸 Reus, Spain

Ospedale San Raffaele; 🇮🇹 Milan, Italy

Hospital Joan XXII of Tarragona; 🇪🇸 Tarragona, Spain

Hospital HM Nuevo Belen; 🇪🇸 Madrid, Spain

Hospital HM Monteprincipe; 🇪🇸 Madrid, Spain