Safety and Efficacy of a Starter Infant Formula With Synbiotics: a Double-blind, Randomized, Controlled Trial

Société des Produits Nestlé (SPN)3 sites in 1 country240 target enrollmentJuly 5, 2023

ConditionsHealthy Infants

InterventionsControl 1st age starter infant formula Experimental 1st age starter infant formula

Overview

Phase: N/A
Intervention: Control 1st age starter infant formula
Conditions: Healthy Infants
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 240
Locations: 3
Primary Endpoint: Safety of experimental formula demonstrated by growth
Status: Active, Not Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.

Registry

clinicaltrials.gov

Start Date

July 5, 2023

End Date

September 1, 2027

Last Updated

3 months 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 at least one of the infant's parent(s)/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
•Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
•Able to temporarily store stool samples in a household freezer.
•Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
•Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.
•Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
•Healthy term infant (≥37 weeks of gestation).
•At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
•Birth weight ≥ 2500g and ≤ 4500g.
•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(s) 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 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).
•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 enrolment 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.
•Infants who are presently receiving or have received prior to enrolment 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.
•Currently participating or having participated in another interventional clinical trial since birth.

Arms & Interventions

Control formula group

The Control Formula group will receive 1st age infant formula exclusively for the first six months.

Intervention: Control 1st age starter infant formula

Experimental formula group

The Experimental Formula group will receive 1st age infant formula identical to Control formula, but supplemented with a HMO blend and a probiotic exclusively for the first six months.

Intervention: Experimental 1st age starter infant formula

Outcomes

Primary Outcomes

Safety of experimental formula demonstrated by growth

Time Frame: Baseline Visit 1 to 4 months of age Visit 5

Weight gain comparison between infants from experimental and control group

Secondary Outcomes

Head circumference (cm)(Baseline Visit 1 to 6 month of age Visit 6)
Length (cm)(Baseline Visit 1 to 6 month of age Visit 6)
Antibiotic and antipyretic use(Baseline Visit 1 to 6 month of age Phone visit 7)
Fecal microbiome(Baseline Visit 1 to 6 month of age Visit 6)
Fecal cytokine profile(Baseline Visit 1 to 6 month of age Visit 6)
Fecal metabolic profile(Baseline Visit 1 to 6 month of age Visit 6)
3-day GI Symptom and Behavior Diary(Baseline Visit 1 to 6 month of age Visit 6)
Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire(Baseline Visit 1 to 6 month of age Visit 6)
Weight (g)(Baseline Visit 1 to 6 month of age Visit 6)
Respiration(Baseline Visit 1 to 6 month of age Visit 6)
Body temperature(Baseline Visit 1 to 6 month of age Visit 6)
Physical examination(Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5)
Efficacy of experimental formula demonstrated by fecal sIgA concentration.(Baseline Visit 1 to 4 months of age Visit 5)
Fecal markers of immune health and gut barrier function(Baseline Visit 1 to 6 month of age Visit 6)
Blood markers of systemic immunity(Baseline Visit 1 to 4 months of age Visit 5)
Heart rate(Baseline Visit 1 to 6 month of age Visit 6)
Pediatric Immune System Index and Infant Illness Questionnaire(Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5)