CompletedNCT01715246Updated Sep 11, 2015

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

An interventional study of Infant Formula in Healthy, sponsored by Société des Produits Nestlé (SPN). Completed at 2 sites in 2 countries. Open to participants aged Up to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-11.

Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 176
Allocation: Randomized
Ages: Up to 14 Days
Sex: All

Study summary

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.

Conditions studied

Healthy

Keywords

healthy babbies
infant formula
growth
HMO

In context

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 14 Days
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Care provider)
Enrollment: 176 participants (estimated)

Study arms

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

Interventions

OtherInfant Formula

What researchers measure

Primary outcomes

Growth
child growth (body weight) from enrollment to 4 months of age
Time frame: 4 months of life

Secondary outcomes

Growth
Time frame: 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
Time frame: 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
Time frame: every month for 6 months
Morbidity
Time frame: ongoing for 1 year
Stool microbiota
Time frame: 3 and 12 months of age
Gene expression
Time frame: 3 and 12 months of age

Study locations

2 sites

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

References and documents

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. PubMed 34576834 ↗
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. PubMed 32184252 ↗
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. PubMed 28107288 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01715246
Lead sponsor: Société des Produits Nestlé (SPN)
Responsible party: Sponsor
First posted: Oct 26, 2012
Start date: Oct 2012
Primary completion: Dec 2014
Completion: Jul 2015
Last update: Sep 11, 2015

Study contacts

Giovanni CORSELLO

principal investigator · Dipartimento Materno Infantile, Palermo

Philippe ALLIET

principal investigator · Kinderartsenpraktijk, Hasselt, Belgium

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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