Starter Infant Formula With Synbiotics

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Infants
• Intervention / Treatment: Other: Control 1st age starter infant formula; Other: Experimental 1st age starter infant formula

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Manila, Philippines
    • Asian Hospital and Medical Center
  • Manila, Philippines
    • University of Perpetual Help DALTA Medical Center
  • Manila, Philippines
    • University of the East Ramon Magsaysay Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
3. Able to temporarily store stool samples in a household freezer.
4. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
5. Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.

6. 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 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
   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(s) must have independently elected, before enrollment, not to breastfeed.
   5. For the breastfed group, infants must have been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established), and their parent(s)/LAR(s) 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 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.
3. 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.
4. Currently participating or having participated in another interventional clinical trial since birth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control formula group; The Control Formula group will receive 1st age infant formula exclusively for the first six months.	Other: Control 1st age starter infant formula; A standard bovine milk-based term infant formula.
Experimental: 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.	Other: Experimental 1st age starter infant formula; Same content as Control formula plus supplemented with a HMO blend and a probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of experimental formula demonstrated by growth	Weight gain comparison between infants from experimental and control group	Baseline Visit 1 to 4 months of age Visit 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of experimental formula demonstrated by fecal sIgA concentration.	Concentration of sIgA in fecal samples	Baseline Visit 1 to 4 months of age Visit 5
Fecal microbiome	Fecal microbiota modulating effect	Baseline Visit 1 to 6 month of age Visit 6
Fecal metabolic profile	Fecal pH, fecal organic acids measurement from fecal samples	Baseline Visit 1 to 6 month of age Visit 6
Blood markers of systemic immunity	Immunotyping and plasma immune proteomics and Vaccine specific antibodies measurement from blood samples	Baseline Visit 1 to 4 months of age Visit 5
3-day GI Symptom and Behavior Diary	GI tolerance, GI symptoms and GI-related behaviors	Baseline Visit 1 to 6 month of age Visit 6
Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire	GI tolerance, GI symptoms and GI-related behaviors	Baseline Visit 1 to 6 month of age Visit 6
Weight (g)	Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2	Baseline Visit 1 to 6 month of age Visit 6
Length (cm)	Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2	Baseline Visit 1 to 6 month of age Visit 6
Head circumference (cm)	Anthropometric measurement	Baseline Visit 1 to 6 month of age Visit 6
Respiration	Vital signs	Baseline Visit 1 to 6 month of age Visit 6
Heart rate	Vital signs	Baseline Visit 1 to 6 month of age Visit 6
Body temperature	Vital signs	Baseline Visit 1 to 6 month of age Visit 6
Physical examination	Infant illness and infection outcomes	Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
Pediatric Immune System Index and Infant Illness Questionnaire	Infant illness and infection outcomes	Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
Antibiotic and antipyretic use	Concomitant medication reporting	Baseline Visit 1 to 6 month of age Phone visit 7
Fecal markers of immune health and gut barrier function	Fecal markers of immune health and gut barrier, such as but not restricted to calprotectin and α-1-antitrypsin assessed by ELISA.	Baseline Visit 1 to 6 month of age Visit 6
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.	Baseline Visit 1 to 6 month of age Visit 6

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: IQVIA Pty Ltd
• Investigators: Principal Investigator: Maria Rosario Capeding, Dr, Asian Hospital Medical Center; Principal Investigator: Mitzi Trinidad Aseron, Dr, University of Perpetual Help DALTA Medical Center; Principal Investigator: Vinna Marie Quinones, Dr, University of the East Ramon Magsaysay Memorial Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Actual): August 14, 2024
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 21.14.INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No