NCT01715246

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable healthy

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 11, 2015

Status Verified

July 1, 2014

Enrollment Period

2.2 years

First QC Date

October 24, 2012

Last Update Submit

September 10, 2015

Conditions

Healthy

Keywords

healthy babbiesinfant formulagrowthHMO

Outcome Measures

Primary Outcomes (1)

  • Growth

    child growth (body weight) from enrollment to 4 months of age

    4 months of life

Secondary Outcomes (6)

  • Growth

    6 and 12 months of age

  • Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)

    every month during 6 months

  • Product compliance (quantity of formula in ml consumed on the 3 days before visit)

    every month for 6 months

  • Morbidity

    ongoing for 1 year

  • Stool microbiota

    3 and 12 months of age

  • +1 more secondary outcomes

Study Arms (3)

Starter infant formula without HMO

PLACEBO COMPARATOR

Volumes of feed depend on age, weight and appetite.

Other: Infant Formula

Starter infant formula with 2 HMOs

ACTIVE COMPARATOR

Volumes of feeds depend on age, weight and appetite

Other: Infant Formula

Breasfed reference group

NO INTERVENTION

Interventions

Infant FormulaOTHER
Starter infant formula with 2 HMOsStarter infant formula without HMO

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kinderartsenpraktijk

Hasselt, 3500, Belgium

Location

Dipartimento Materno Infantile

Palermo, 90127, Italy

Location

Related Publications (4)

  • Tarrant I, Finlay BB. Human milk oligosaccharides: potential therapeutic aids for allergic diseases. Trends Immunol. 2023 Aug;44(8):644-661. doi: 10.1016/j.it.2023.06.003. Epub 2023 Jul 11.

    PMID: 37438187DERIVED

  • 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.

    PMID: 34576834DERIVED

  • 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.

    PMID: 32184252DERIVED

  • 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.

    PMID: 28107288DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Giovanni CORSELLO

    Dipartimento Materno Infantile, Palermo

    PRINCIPAL INVESTIGATOR

  • Philippe ALLIET

    Kinderartsenpraktijk, Hasselt, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 26, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

September 11, 2015

Record last verified: 2014-07

Locations

IT(1)BE(1)