Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s)

Société des Produits Nestlé (SPN)318 enrolled

Overview

This is a randomized, controlled, multicenter, double-blind study of healthy term infants. The primary objective of the trial is to demonstrate the safety of a a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age.

This is a randomized, controlled, multicenter, double-blind study of healthy term infants, consisting of two randomized formula-fed arms (control and experimental formulas) and a non-randomized breast-fed reference group. The population under investigation are healthy infants aged ≤14 days at enrollment. The planned sample size for formula-fed infants is 236 (118 per study group). A non-randomized breastfed reference group of 90 healthy, term, exclusively breastfed infants up to 4 months will also be enrolled. Study formulas are administrated orally, ad libitum, from enrollment until 15 months of age. The primary objective of the trial is to demonstrate the safety of a starter infant formula supplemented with pre- and probiotic(s) by comparing the growth (weight gain, g/day) of infants randomized to the experimental formula versus the control formula from enrolment to 4 months of age. In addition fecal microbiome, fecal metabolic profile, fecal markers of immune and gut health, blood markers of immune health (in a subset of 60 infants/group), GI tolerance, bone index (subset of 40 infants/group), other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

318

Conditions

Healthy Infants

Interventions

Experimental formulas (EF)OTHER

First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months

Control formulas (CF)OTHER

First age formula administered orally ad libitum until 6 months of age, switch to second age formula until 12 months and finally to growing-up milk from 12 to 15 months

Breast feeding (BF)OTHER

Exclusive breast feeding up to 4 months

Eligibility

Sex: ALLMin age: 0 DaysMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study. 2. Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted. 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 must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Healthy term infant (≥37 weeks of gestation) 2. At enrollment visit, post-natal age ≤14 days/0.5 months 3. Birth weight ≥ 2500g and ≤ 4500g. 4. For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR must have independently elected, before enrollment, not to breastfeed. 5. For the breastfed group, infants must have been exclusively consuming breast milk since birth, and their parent(s)/LAR must have made the decision to continue exclusively breastfeeding until at least 4 months of age. Exclusion Criteria: 1. Infants with conditions requiring infant feedings other than those specified in the protocol. 2. 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, including: 1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation) 2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis) 3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. Of note, children who are normally healthy but at the time of enrollment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled. 3. Infants who are presently receiving or have received prior to enrollment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion. 4. Currently participating or having participated in another clinical trial since birth. 5. Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol

Locations (18)

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Outcomes

Primary Outcomes

Weight

Weight gain measured as mean daily weight gain in g/day

Time frame: From baseline (≤14 days) to 4 months of age

Secondary Outcomes

Bifidobacteria abundance

Time frame: At 90 days (3 months of age)

Fecal microbiome

Overall fecal microbiota composition, diversity, different bacteria taxa and microbiota community types assessed using next generation sequencing (NGS) technology

Time frame: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

Fecal metabolic profile: fecal pH

Fecal pH

Time frame: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

Fecal metabolic profile: fecal organic acids

Fecal organic acids (such as, but not restricted to lactate, including indole-lactate, L- and D-lactate, propionate, butyrate, acetate, valerate, and total fecal organic acids)

Time frame: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

Fecal markers of immune health and gut barrier

Fecal markers of immune health and gut barrier such as total secretory IgA (sIgA), lipocalin-2, calprotectin, and α-1-antitrypsin assessed by ELISA.

Time frame: Stool sample collected at ≤14 days (baseline), 3, 6, 12 and 15 months of age

Fecal cytokine profile

Fecal cytokine profile (such as but not restricted to: IL-6, IL-8, IL-1b, IL-22, IFN-γ) using multiplex assays

Data from ClinicalTrials.gov

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