Clinical trial NCT01715246: Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
Official title: Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy babbies
infant formula
growth
HMO
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 176
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Growth
timeFrame: 4 months of life
Secondary outcomes:
measure: Growth
timeFrame: 6 and 12 months of age
measure: Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)
timeFrame: every month during 6 months
measure: Product compliance (quantity of formula in ml consumed on the 3 days before visit)
timeFrame: every month for 6 months
measure: Morbidity
timeFrame: ongoing for 1 year
measure: Stool microbiota
timeFrame: 3 and 12 months of age
measure: Gene expression
timeFrame: 3 and 12 months of age
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Kinderartsenpraktijk
city: Palermo
country: Italy
facility: Dipartimento Materno Infantile
Study officials:
affiliation: Dipartimento Materno Infantile, Palermo
name: Giovanni CORSELLO
role: PRINCIPAL_INVESTIGATOR
affiliation: Kinderartsenpraktijk, Hasselt, Belgium
name: Philippe ALLIET
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.