Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Infant Formula

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Kinderartsenpraktijk
• Italy
  • Palermo, Italy, 90127
    • Dipartimento Materno Infantile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy babies
• Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
• birth weight between 2500 g- 4500g
• Having obtained the baby's legal representative's informed consent.
• FF groups:

babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed

• BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.

Exclusion Criteria:

• Congenital illness or malformation that may affect growth
• Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
• Minor parent(s)
• Newborn whose parents / caregivers cannot be expected to comply with study procedures
• Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Starter infant formula without HMO; Volumes of feed depend on age, weight and appetite.	Other: Infant Formula
Active Comparator: Starter infant formula with 2 HMOs; Volumes of feeds depend on age, weight and appetite	Other: Infant Formula
No Intervention: Breasfed reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	child growth (body weight) from enrollment to 4 months of age	4 months of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth		6 and 12 months of age
Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)	Parents are asked to complete a diary on digistive tolerance of their child	every month during 6 months
Product compliance (quantity of formula in ml consumed on the 3 days before visit)	Parents are asked to complete a diary on the product compliance	every month for 6 months
Morbidity		ongoing for 1 year
Stool microbiota		3 and 12 months of age
Gene expression		3 and 12 months of age

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Giovanni CORSELLO, Dipartimento Materno Infantile, Palermo; Principal Investigator: Philippe ALLIET, Kinderartsenpraktijk, Hasselt, Belgium

Publications and helpful links

General Publications

• Dogra SK, Martin FP, Donnicola D, Julita M, Berger B, Sprenger N. Human Milk Oligosaccharide-Stimulated Bifidobacterium Species Contribute to Prevent Later Respiratory Tract Infections. Microorganisms. 2021 Sep 12;9(9):1939. doi: 10.3390/microorganisms9091939.
• Berger B, Porta N, Foata F, Grathwohl D, Delley M, Moine D, Charpagne A, Siegwald L, Descombes P, Alliet P, Puccio G, Steenhout P, Mercenier A, Sprenger N. Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics. mBio. 2020 Mar 17;11(2):e03196-19. doi: 10.1128/mBio.03196-19.
• Puccio G, Alliet P, Cajozzo C, Janssens E, Corsello G, Sprenger N, Wernimont S, Egli D, Gosoniu L, Steenhout P. Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):624-631. doi: 10.1097/MPG.0000000000001520.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: growth; HMO; infant formula; healthy babbies
• Other Study ID Numbers: 11.26.INF