Growth of Infants Fed a New Term Infant Formula

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Infant formula (CF); Dietary Supplement: Infant Formula (EF)

• Registration Number: NCT03090360
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

To evaluate the growth of healthy term infants fed an experimental infant formula with a prebiotic, a commercial control infant formula with a probiotic, but without a prebiotic and human breast milk

Detailed Description

Multisite, double-blind, randomized, controlled clinical trial. The purpose of the study is to determine if infants fed a standard infant formula with a prebiotic have a weight gain in line with infants fed a standard starter infant formula without a prebiotic.

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Primary Completion: 2019-04-11
• Study Completion: 2019-05-21
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-03
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

1. Written informed consent signed and dated
2. Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
4. Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
5. Infants whose parent(s)/LAR have a working freezer.
6. Healthy term, singleton infant at birth.
7. At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
8. At enrollment, birth weight ≥ 2500g and ≤ 4500g.
9. For formula-fed group, infant of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment.

Exclusion Criteria

1. Infants with conditions requiring infant feedings other than those specified in the protocol.
2. Infants receiving complementary foods or liquids.
3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results.
4. Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
5. Infants or infants whose parent(s)/LAR who in the Investigator's assessment cannot be expected to comply with the protocol or with study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo comparator (Control)	Infant formula (CF)	Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite.
Experimental Formula (Test)	Infant Formula (EF)	Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite.

Primary Outcome Measures

Name	Time	Method
Growth	120 days	Growth (weight gain velocity)

Secondary Outcome Measures

Name	Time	Method
Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)	Every month up to 4 months of age	Fecal microbiota composition, diversity, and abundance
Fecal markers (pH, fecal organic acids, and protein markers of gut health)	Every month up to 4 months of age	Fecal markers (pH, fecal organic acids, and protein markers of gut health)
Growth	Every month up to 6 months of age	Other growth outcomes will be compared to the World Health Organization 2006 Growth Standards and by treatment group
Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)	Every month up to 6 months of age	Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)	Every month up to 6 months of age	GI tolerance (3-day GI symptom and behavior diary - including GI symptoms (frequency and amount of spitting-up/vomiting, and frequency of flatulence), GI-related behaviors (duration of crying and fussiness, sleeping, and the frequency of excessive crying episodes), and milk intake)
Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)	Up to 3 months of age	Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
Adverse events / Morbidity	180 days	Adverse events / Morbidity

Trial Locations

Locations (7)

Clinique Ste Elisabeth; 🇧🇪 Namur, Belgium

CHwapi; 🇧🇪 Tournai, Belgium

Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

AOUP "Paolo Giaccone"; 🇮🇹 Palermo, Italy

Algemeen Stedelijk Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

Kinderartsen Huis5; 🇧🇪 Hasselt, Belgium