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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715246
• Other study ID #: 11.26.INF
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: September 10, 2015
• Start date: October 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Infant Formula

Locations

Country	Name	City	State
Belgium	Kinderartsenpraktijk	Hasselt
Italy	Dipartimento Materno Infantile	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	child growth (body weight) from enrollment to 4 months of age	4 months of life	No
Secondary	Growth		6 and 12 months of age	No
Secondary	Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)	Parents are asked to complete a diary on digistive tolerance of their child	every month during 6 months	No
Secondary	Product compliance (quantity of formula in ml consumed on the 3 days before visit)	Parents are asked to complete a diary on the product compliance	every month for 6 months	No
Secondary	Morbidity		ongoing for 1 year	No
Secondary	Stool microbiota		3 and 12 months of age	No
Secondary	Gene expression		3 and 12 months of age	No