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OpenTrials
Completed

NCT Number: NCT01715246

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.

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Key information

Conditions

Healthy

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kinderartsenpraktijk, Hasselt, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infant Formula

Other

Primary outcomes

  1. Growth

    Time frame: 4 months of life

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

Secondary outcomes

  1. Growth

    Time frame: 6 and 12 months of age

  2. 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

  3. 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

  4. Morbidity

    Time frame: ongoing for 1 year

  5. Stool microbiota

    Time frame: 3 and 12 months of age

  6. Gene expression

    Time frame: 3 and 12 months of age

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 26, 2012
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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