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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Starter infant formula without HMO

Volumes of feed depend on age, weight and appetite.

Group Type PLACEBO_COMPARATOR

Infant Formula

Intervention Type OTHER

Starter infant formula with 2 HMOs

Volumes of feeds depend on age, weight and appetite

Group Type ACTIVE_COMPARATOR

Infant Formula

Intervention Type OTHER

Breasfed reference group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Infant Formula

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes