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

This study has been completed.
Information provided by (Responsible Party):
Nestlé Identifier:
First received: October 24, 2012
Last updated: September 10, 2015
Last verified: July 2014
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.

Condition Intervention
Other: Infant Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

Resource links provided by NLM:

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Growth [ Time Frame: 4 months of life ]
    child growth (body weight) from enrollment to 4 months of age

Secondary Outcome Measures:
  • Growth [ Time Frame: 6 and 12 months of age ]
  • Digestive tolerance (stool charecteristics, bowel movements,behavior patterns) [ Time Frame: every month during 6 months ]
    Parents are asked to complete a diary on digistive tolerance of their child

  • Product compliance (quantity of formula in ml consumed on the 3 days before visit) [ Time Frame: every month for 6 months ]
    Parents are asked to complete a diary on the product compliance

  • 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 ]

Estimated Enrollment: 176
Study Start Date: October 2012
Study Completion Date: July 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01715246

Hasselt, Belgium, 3500
Dipartimento Materno Infantile
Palermo, Italy, 90127
Sponsors and Collaborators
Principal Investigator: Giovanni CORSELLO Dipartimento Materno Infantile, Palermo
Principal Investigator: Philippe ALLIET Kinderartsenpraktijk, Hasselt, Belgium
  More Information

Responsible Party: Nestlé Identifier: NCT01715246     History of Changes
Other Study ID Numbers: 11.26.INF
Study First Received: October 24, 2012
Last Updated: September 10, 2015

Keywords provided by Nestlé:
healthy babbies
infant formula
HMO processed this record on May 25, 2017