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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Infant Formula

• Registration Number: NCT01715246
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-26
• Status Verified: 2014-07
• Primary Completion: 2014-12
• Study Completion: 2015-07
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Starter infant formula without HMO	Infant Formula	Volumes of feed depend on age, weight and appetite.
Starter infant formula with 2 HMOs	Infant Formula	Volumes of feeds depend on age, weight and appetite

Primary Outcome Measures

Name	Time	Method
Growth	4 months of life	child growth (body weight) from enrollment to 4 months of age

Secondary Outcome Measures

Name	Time	Method
Growth	6 and 12 months of age
Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)	every month during 6 months	Parents are asked to complete a diary on digistive tolerance of their child
Stool microbiota	3 and 12 months of age
Gene expression	3 and 12 months of age
Product compliance (quantity of formula in ml consumed on the 3 days before visit)	every month for 6 months	Parents are asked to complete a diary on the product compliance
Morbidity	ongoing for 1 year

Trial Locations

Locations (2)

Dipartimento Materno Infantile; 🇮🇹 Palermo, Italy

Kinderartsenpraktijk; 🇧🇪 Hasselt, Belgium