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

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.

Study Overview

• Status: Completed
• Conditions: Infant Nutrition
• Intervention / Treatment: Dietary supplement: human milk oligosaccharides

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 Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68161
    • Facharzt für Kinder und Jugendmedizin
  • Rostock, Germany, 18059
    • Klinikum Südstadt Rostock
• Italy
  • Brescia, Italy, 25123
    • ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini
  • Milan, Italy, 20132
    • Ospedale San Raffaele
• Spain
  • Madrid, Spain, 28015
    • Hospital HM Puerta del Sur
  • Madrid, Spain, 28660
    • Hospital HM Montepríncipe
  • Madrid, Spain, 28938
    • Hospital HM Nuevo Belen
  • Reus, Spain, 43204
    • Hospital Universitario Sant Joan de Reus
  • Tarragona, Spain, 43005
    • Hospital Joan XXII of Tarragona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: infant formula containing five HMOs	Dietary supplement: human milk oligosaccharides; mixture of five different human milk oligosaccharides
No Intervention: infant formula
No Intervention: breast milk group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of body weight (in grams) of term infants	growth, assessed by body weight gain, of term infants from enrollment to 4 month of life	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of body length (in centimeter) of term infants	growth, assessed as body length, of term infants from enrollment to 4 month of life	4 month
assessment of head circumference (in centimeter) of term infants	growth, assessed as head circumference, of term infants from enrollment to 4month of life	4 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
digestive tolerance	stool frequency and consistency	4 month
influence of digestion	digestive tolerance parameters ( e.g. rigurgitation, flatulence) will be assessed	4 month
influence on behaviour	behavior patterns (e.g.fussiness, cramps, awakings at night) will be assessed	4 month
product compliance	intake of infant formula in ml	4 month
morbidity	observation of illness	4 month
stool microbiota	analysis of the fecal microbiota	4 month
HMO composition in breast milk	analysis of HMO composition in mothers breastmilk in the breast-fed arm	4 month

Collaborators and Investigators

• Sponsor: Jennewein Biotechnologie GmbH
• Collaborators: Analyze & Realize
• Investigators: Principal Investigator: Frank Jochum, Dr. med., Universitaetsmedizin Berlin, Charité

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: infant formula; human milk oligosaccharides
• Other Study ID Numbers: JEN/008017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No