Clinical trial NCT03090360: Growth of Infants Fed a New Term Infant Formula
Official title: Growth of Infants Fed a New Term Infant Formula With a Prebiotic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy babies
Infant formula
Growth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 349
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Growth
timeFrame: 120 days
Secondary outcomes:
measure: Growth
timeFrame: Every month up to 6 months of age
measure: Stool patterns (3-day GI symptom and behavior diary - stool frequency and stool consistency)
timeFrame: Every month up to 6 months of age
measure: GI tolerance (3-day GI symptom and behavior diary - including GI symptoms, GI-related behaviors, and milk intake)
timeFrame: Every month up to 6 months of age
measure: Fecal microbiota composition and diversity (16S rRNA sequencing and qPCR)
timeFrame: Every month up to 4 months of age
measure: Fecal markers (pH, fecal organic acids, and protein markers of gut health)
timeFrame: Every month up to 4 months of age
measure: Gene expression (infant exfoliated and microbial cell gene expression by shotgun sequencing)
timeFrame: Up to 3 months of age
measure: Adverse events / Morbidity
timeFrame: 180 days
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis Aalst
city: Brussel
country: Belgium
facility: UZ Brussel
city: Hasselt
country: Belgium
facility: Kinderartsen Huis5
city: Namur
country: Belgium
facility: Clinique Ste Elisabeth
city: Tournai
country: Belgium
facility: CHwapi
city: Milano
country: Italy
facility: Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda, Ospedale Maggiore Policlinico
city: Palermo
country: Italy
facility: AOUP "Paolo Giaccone"
Study officials:
affiliation: Kinderartsen Huis 5
name: Philippe Alliet
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.