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

Nestlé

Status: Completed

Conditions: Healthy

Treatments: Other: Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01715246

11.26.INF

Details and patient eligibility

About

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.

Enrollment: 176 estimated patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 3 patient groups, including a placebo group

Starter infant formula without HMO

Placebo Comparator group

Description:

Volumes of feed depend on age, weight and appetite.

Treatment:

Other: Infant Formula

Starter infant formula with 2 HMOs

Active Comparator group

Description:

Volumes of feeds depend on age, weight and appetite

Treatment:

Other: Infant Formula

Breasfed reference group

No Intervention group