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

This study is currently recruiting participants.
Verified November 2013 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01715246
First received: October 24, 2012
Last updated: November 22, 2013
Last verified: November 2013

October 24, 2012
November 22, 2013
October 2012
November 2014   (final data collection date for primary outcome measure)
Growth [ Time Frame: 4 months of life ] [ Designated as safety issue: No ]
child growth (body weight) from enrollment to 4 months of age
Same as current
Complete list of historical versions of study NCT01715246 on ClinicalTrials.gov Archive Site
  • Growth [ Time Frame: 6 and 12 months of age ] [ Designated as safety issue: No ]
  • Digestive tolerance (stool charecteristics, bowel movements,behavior patterns) [ Time Frame: every month during 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Parents are asked to complete a diary on the product compliance
  • Morbidity [ Time Frame: ongoing for 1 year ] [ Designated as safety issue: No ]
  • Stool microbiota [ Time Frame: 3 and 12 months of age ] [ Designated as safety issue: No ]
  • Gene expression [ Time Frame: 3 and 12 months of age ] [ Designated as safety issue: No ]
  • Growth [ Time Frame: 6 and 12 months of age ] [ Designated as safety issue: No ]
  • Digestive tolerance [ Time Frame: every month during 6 months ] [ Designated as safety issue: No ]
  • Product compliance [ Time Frame: every month for 6 months ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: ongoing for 1 year ] [ Designated as safety issue: No ]
  • Stool microbiota [ Time Frame: 3 and 12 months of age ] [ Designated as safety issue: No ]
  • Gene expression [ Time Frame: 3 and 12 months of age ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Healthy
Other: Infant Formula
  • Placebo Comparator: Starter infant formula without HMO
    Volumes of feed depend on age, weight and appetite.
    Intervention: Other: Infant Formula
  • Active Comparator: Starter infant formula with 2 HMOs
    Volumes of feeds depend on age, weight and appetite
    Intervention: Other: Infant Formula
  • No Intervention: Breasfed reference group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
176
April 2015
November 2014   (final data collection date for primary outcome measure)

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.
Both
up to 14 Days
Yes
Not Provided
Belgium,   Italy
 
NCT01715246
11.26.INF
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Giovanni CORSELLO Dipartimento Materno Infantile, Palermo
Principal Investigator: Philippe ALLIET Kinderartsenpraktijk, Hasselt, Belgium
Nestlé
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP