Growth, Safety and Efficacy of a Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides: a Double-blind, Randomized, Controlled Trial

Société des Produits Nestlé (SPN)34 sites in 3 countries789 target enrollmentSeptember 19, 2018

ConditionsHealthy Infants

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy Infants
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 789
Locations: 34
Primary Endpoint: To compare recurrent incidences of illness of infants between the groups
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs.

There will be different groups in the trial: three formula-fed groups and a breastfed group.

Detailed Description

These 5 HMOs are identical to the ones found naturally in human milk. They are natural prebiotics (or complex sugars) with potential health benefits. Prebiotics are natural compounds that help the establishment of beneficial gut bacteria (such as bifidobacteria), while preventing bad bacteria from doing harm. Supplementing diets with certain prebiotics has been shown to be well tolerated in adults and infants and to provide potential benefits.Therefore, the trial also aims to understand if consuming HMOs supplemented formulas could strengthen immunity and prevent common illnesses (for example, respiratory illnesses) in infants and toddlers. Furthermore, stool frequency and consistency will be monitored, so as to evaluate digestive tolerance to the formula.

Registry

clinicaltrials.gov

Start Date

September 19, 2018

End Date

January 19, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/Legally Acceptable Representative has been informed of all pertinent aspects of the study.
•Infants whose parent(s)/Legally Acceptable Representative have reached the legal age of majority in the countries where the study is conducted.
•Infants whose parent(s)/Legally Acceptable Representative are willing and able to comply with scheduled visits, and the requirements of the study protocol.
•Infants whose parent(s)/Legally Acceptable Representative are able to be contacted directly by telephone throughout the study.
•Infants whose parent(s)/Legally Acceptable Representative have a working freezer.
•Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
•Healthy term (37-42 weeks of gestation) infant at birth.
•At enrollment visit, post-natal age ≥ 7 days and ≤ 21 days (date of birth = day 0, 0.25 - 0.75 months old).
•At enrollment, birth weight ≥ 2500g and ≤ 4500g.
•For formula-fed group, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/Legally Acceptable Representative must have independently elected, before enrollment, not to breastfeed.

Exclusion Criteria

•Infants with conditions requiring infant feedings other than those specified in the protocol.
•Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
•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:
•Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
•Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
•History of admission to the Neonatal Intensive Care Unit (NICU), with the exception of admission for jaundice phototherapy.
•Other 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.
•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 characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion; or any study outcomes.
•Currently participating or having participated in another clinical trial since birth

Outcomes

Primary Outcomes

To compare recurrent incidences of illness of infants between the groups

Time Frame: From Study Day 1 to 15 months of age

To compare recurrent incidences of illness (specifically lower and upper respiratory tract illnesses including bronchitis/bronchiolitis), of infants randomized to Test Groups (TG1 or TG2) versus Control Group (CG)

To compare the growth of infants between the groups

Time Frame: From Study Day 1 to 4 months of age

To compare the growth (weight gain, g/day) of infants randomized to Test Groups (TG1 or TG2) versus Control Group (CG)

Secondary Outcomes

Absenteeism: Time away from daycare (infant) or work (parent)(From enrollment until 15 months of age)
Blood Markers of immune health(At 6 months of age)
Gastrointestinal tolerance(Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants))
Anthropometric measurements: Weight(From enrollment until 15 months of age)
Anthropometric measurements: Length(From enrollment until 15 months of age)
Anthropometric measurements: Head circumference(From enrollment until 15 months of age)
Breastmilk collection for Human Milk Oligosaccharides profile analysis (breastfeeding mothers only)(At Study Day 90 +/- 5 days)
Anthropometric measurements: World Health Organization (WHO) growth standard calculated z-scores(From enrollment until 15 months of age)
Standard adverse events (AEs) reporting for safety assessment(From the time the informed consent form has been signed at enrollment infant age less than 21 days or 0.75 months through the 2 weeks post-study telephone contact at infant age 464 days)
Vital signs: Body temperature(From enrollment until 15 months of age)
Bone index measurement(From enrollment until 15 months of age)
Infant illness and infection outcomes(at different stages of feeding 1st age Infant Formula, 2nd age Follow-up Formula, and 3rd age Growing-up Milk when applicable)
Fecal microbiome composition, diversity, community type(Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants))
Fecal metabolic profile(Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants))
Cognitive and behavioral outcomes(At 15 months of age)
Anthropometric measurements: BMI(From enrollment until 15 months of age)
Vital signs: Heart rate(From enrollment until 15 months of age)
Dietary pattern(From 6 months of age until 15 months of age)
Medication use (specifically antimicrobials and antipyretics)(From enrollment until 15 months of age)
Markers of immune and gut health(Stool sample collected at infant age less than 0.75, 3, 6, 12, and 15 months of age (a subset of 105 infants per formula group; 90 breastfed infants))
DNA Genotyping of fucosyltransferase 2 and 3 (secretor status)(At Study Day 60 +/- 5 days)
Vital signs: Infant respiration(From enrollment until 15 months of age)