Growth of Infants Fed a New Term Infant Formula

NCT03090360 | Completed DMC

• 1 other identifier: 16.07.INF
• Study Type: interventional
• Target: 349
• Locations: 2 countries
• Sites: 7

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

Conditions

Healthy

Keywords

Healthy babies; Infant formula; Growth

Outcome Measures

Primary Outcomes (1)

• Growth

  Growth (weight gain velocity)

  120 days

Secondary Outcomes (7)

• Growth

  Every month up to 6 months of age

• 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)

  Every month up to 6 months of age

• Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)

  Every month up to 4 months of age

• Fecal markers (pH, fecal organic acids, and protein markers of gut health)

  Every month up to 4 months of age

Study Arms (3)

Placebo comparator (Control)

PLACEBO COMPARATOR

Starter infant formula with a probiotic and without a prebiotic. Volumes of feed depend on age, weight and appetite.

Dietary Supplement: Infant formula (CF)

Experimental Formula (Test)

EXPERIMENTAL

Starter infant formula with a probiotic and prebiotic. Volumes of feed depend on age, weight and appetite.

Dietary Supplement: Infant Formula (EF)

Breastfed reference group

NO INTERVENTION

Breastfed reference group

Interventions

Infant formula (CF) DIETARY_SUPPLEMENT

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.

Placebo comparator (Control)

Infant Formula (EF) DIETARY_SUPPLEMENT

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 Formula (Test)

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent signed and dated
• Infants whose parent(s)/Legally Authorized Representative (LAR) have reached the legal age of majority in Belgium
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study.
• Infants whose parent(s)/LAR have a working freezer.
• Healthy term, singleton infant at birth.
• At enrollment visit, post-natal age ≤ 14 days (date of birth = day 0).
• At enrollment, birth weight ≥ 2500g and ≤ 4500g.
• 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.

You may not qualify if:

• Infants with conditions requiring infant feedings other than those specified in the protocol.
• Infants receiving complementary foods or liquids.
• 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.
• Infants who are presently receiving or have received prior to enrollment medications that could interfere with the interpretation of study results.
• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (7)

Algemeen Stedelijk Ziekenhuis Aalst

Aalst, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Kinderartsen Huis5

Hasselt, 3500, Belgium

Location

Clinique Ste Elisabeth

Namur, Belgium

Location

CHwapi

Tournai, Belgium

Location

Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico

Milan, Italy

Location

AOUP "Paolo Giaccone"

Palermo, Italy

Location

Related Publications (1)

• 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.

  PMID: 35193609 DERIVED

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Officials

• Philippe Alliet

  Kinderartsen Huis 5

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 24, 2017
• Study Start: February 21, 2017
• Primary Completion: April 11, 2019
• Study Completion: May 21, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5); IT (2)