Starter Infant Formula With Synbiotics

January 13, 2026 updated by: Société des Produits Nestlé (SPN)

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline Visit 1 to 4 months of age Visit 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of experimental formula demonstrated by fecal sIgA concentration.
Time Frame: Baseline Visit 1 to 4 months of age Visit 5
Concentration of sIgA in fecal samples
Baseline Visit 1 to 4 months of age Visit 5
Fecal microbiome
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
Fecal microbiota modulating effect
Baseline Visit 1 to 6 month of age Visit 6
Fecal metabolic profile
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
Fecal pH, fecal organic acids measurement from fecal samples
Baseline Visit 1 to 6 month of age Visit 6
Blood markers of systemic immunity
Time Frame: Baseline Visit 1 to 4 months of age Visit 5
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
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
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
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
GI tolerance, GI symptoms and GI-related behaviors
Baseline Visit 1 to 6 month of age Visit 6
Weight (g)
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
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)
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
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)
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
Anthropometric measurement
Baseline Visit 1 to 6 month of age Visit 6
Respiration
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
Vital signs
Baseline Visit 1 to 6 month of age Visit 6
Heart rate
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
Vital signs
Baseline Visit 1 to 6 month of age Visit 6
Body temperature
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
Vital signs
Baseline Visit 1 to 6 month of age Visit 6
Physical examination
Time Frame: Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
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
Time Frame: Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
Infant illness and infection outcomes
Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
Antibiotic and antipyretic use
Time Frame: Baseline Visit 1 to 6 month of age Phone visit 7
Concomitant medication reporting
Baseline Visit 1 to 6 month of age Phone visit 7
Fecal markers of immune health and gut barrier function
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
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
Time Frame: Baseline Visit 1 to 6 month of age Visit 6
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Pty Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 14, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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