Growth of Infants Fed a New Term Infant Formula

Growth of Infants Fed a New Term Infant Formula With a Prebiotic

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Infant formula (CF); Dietary supplement: Infant Formula (EF)

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 Type: Interventional
• Enrollment (Actual): 349
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • Algemeen Stedelijk Ziekenhuis Aalst
  • Brussel, Belgium
    • UZ Brussel
  • Hasselt, Belgium, 3500
    • Kinderartsen Huis5
  • Namur, Belgium
    • Clinique Ste Elisabeth
  • Tournai, Belgium
    • CHwapi
• Italy
  • Milano, Italy
    • Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico
  • Palermo, Italy
    • AOUP "Paolo Giaccone"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 weeks (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo comparator (Control); Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite.	Dietary supplement: Infant formula (CF); Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
EXPERIMENTAL: Experimental Formula (Test); Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite.	Dietary supplement: Infant Formula (EF); Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
NO_INTERVENTION: Breastfed reference group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth	Growth (weight gain velocity)	120 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Philippe Alliet, Kinderartsen Huis 5

Publications and helpful links

General Publications

• Alliet P, Vandenplas Y, Roggero P, Jespers SNJ, Peeters S, Stalens JP, Kortman GAM, Amico M, Berger B, Sprenger N, Cercamondi CI, Corsello G. Safety and efficacy of a probiotic-containing infant formula supplemented with 2'-fucosyllactose: a double-blind randomized controlled trial. Nutr J. 2022 Feb 22;21(1):11. doi: 10.1186/s12937-022-00764-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2017
• Primary Completion (ACTUAL): April 11, 2019
• Study Completion (ACTUAL): May 21, 2019

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Infant formula; Growth; Healthy babies
• Other Study ID Numbers: 16.07.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No