Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Infant Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513744
• Other study ID #: JEN/008017
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: April 5, 2021

Study information

• Verified date: October 2023
• Source: Jennewein Biotechnologie GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: April 5, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 13 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Nutrition

Intervention

Dietary Supplement:
• human milk oligosaccharides
mixture of five different human milk oligosaccharides

Locations

Country	Name	City	State
Germany	Facharzt für Kinder und Jugendmedizin	Mannheim
Germany	Klinikum Südstadt Rostock	Rostock
Italy	ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini	Brescia
Italy	Ospedale San Raffaele	Milan
Spain	Hospital HM Monteprincipe	Madrid
Spain	Hospital HM Nuevo Belen	Madrid
Spain	Hospital HM Puerta del Sur	Madrid
Spain	Hospital Universitario Sant Joan de Reus	Reus
Spain	Hospital Joan XXII of Tarragona	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
Jennewein Biotechnologie GmbH	Analyze & Realize

Countries where clinical trial is conducted

Germany,  Italy,  Spain, 

Outcome

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