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

This study is currently recruiting participants.
Verified May 2013 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01715246
First received: October 24, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Healthy
 Other: Infant Formula

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Growth [ Time Frame: 4 months of life ] [ Designated as safety issue: No ]
    child growth (body weight) from enrollment to 4 months of age


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 176
Study Start Date: October 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 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

  Eligibility

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715246

Locations
Belgium
Kinderartsenpraktijk Recruiting
Hasselt, Belgium, 3500
Contact: ALLIET     + 32 11 30 98 65     philippe.alliet@jessazh.be    
Principal Investigator: ALLIET            
Italy
Dipartimento Materno Infantile Not yet recruiting
Palermo, Italy, 90127
Contact: CORSELLO            
Principal Investigator: CORSELLO            
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Giovanni CORSELLO Dipartimento Materno Infantile, Palermo
Principal Investigator: Philippe ALLIET Kinderartsenpraktijk, Hasselt, Belgium
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01715246     History of Changes
Other Study ID Numbers: 11.26.INF
Study First Received: October 24, 2012
Last Updated: May 15, 2013
Health Authority: Belgium: Ethics Committee
Italy: Ethics Committee

Keywords provided by Nestlé:
healthy babbies
infant formula
growth
HMO

ClinicalTrials.gov processed this record on May 23, 2013