A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants. (GAIA)

March 18, 2026 updated by: Nutricia Research

To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test Product, compared to subjects receiving the Control Product. Also, other anthropometric parameters will be investigated up to 52 weeks.

A Breastfed reference group, exclusively breastfed for at least 16 weeks, will also be included.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

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.

Detailed Description

The study will include infants to be randomised to receive the Test or Control product for 52, and infants whose parents have the intention to provide exclusively breastfeeding for at least 16 weeks after enrolment. Baseline assessments will be done at Visit 1/enrolment visits.

Subjects will return for clinic visits at 2 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6) 26 (Visit 7), 39 (Visit 8), and 52 (Visit 9) weeks post-baseline. During these clinic visits the investigator will perform anthropometric measurements, interview parent(s) about their infant's product intake/breastfeeding, occurrence of (serious) adverse events, medication/nutritional supplement use, details of infections and antibiotic/antiviral usage (if applicable).

At selected visits the following will be assessed a) stool characteristics (V2, 4, 6, 7,8, 9)); b) type of weaning food introduction (as of V6); c) neurocognitive development (V9); d) a three-day 24 hour food recall for dietary intake; e) stool samples at (V1, 6, 9); and f) blood sample (V6).

Also, a follow-up phone call is planned 2 weeks after the last visit.

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 (Estimated)

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.
579

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

  • Bulgaria
      • Dupnitsa, Bulgaria, 2600
        • Medical Centre Asklepiy OOD Dupinista
  • Poland
    • Lesser Poland Voivodeship
      • Katowice, Lesser Poland Voivodeship, Poland, 40-851
        • Gyncentrum Spółka Z Ograniczoną Odpowiedzialnością,

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:

  • Healthy, singleton, term born infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days).
  • Infants aged ≤ 14 days at enrolment.
  • Weight at birth within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards
  • For formula feeding groups: Infants fully formula fed at the time of enrolment.
  • For breastfed reference group: Infants exclusively breastfed at the time of enrolment and parent(s) intend to exclusively breastfeed the infant at least until 16 weeks after Visit 1.
  • Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.

Exclusion Criteria:

  • . Infants who require a special diet other than IF with intact cow's milk protein.
  • Infants known or suspected to have cow's milk, fish, and/or soy allergy and/or lactose intolerance.
  • Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
  • Infants whose mother is known to suffer from an illness or condition which could interfere with the study outcomes, as per investigator's clinical judgement.
  • Infants with previous, current, or intended participation in any concomitant clinical study involving investigational or marketed products.
  • Investigator's uncertainty about the willingness or ability of parents or legally acceptable representative(s) to comply with the protocol requirements.

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: Basic Science
  • 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.
Experimental: Arm 1
Infant formula test group; Group that receives the test product.
Other: Infant Formula
Test group
Active Comparator: Arm 2
Infant formula control group; Group that receives a comparative control product.
Other: Infant Formula
Test group

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
Weight gain
Time Frame: Baseline to 16 weeks post-baseline
To demonstrate equivalence in mean weight gain per day from baseline to 16 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product
Baseline to 16 weeks post-baseline

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
Neurocognitive Development
Time Frame: 52 weeks post baseline
Demonstrate better neurocognitive development as measured by the Bayley Scales of Infant and Toddler Development (Bayley-3) cognitive composite score at 52 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product.
52 weeks post baseline

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.
Nutricia Research

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 17, 2024

Primary Completion (Estimated)

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.
June 30, 2027

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.
December 31, 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).
June 21, 2024

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.
June 21, 2024

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.
June 26, 2024

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.
March 23, 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.
March 18, 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.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • SBB22R&56319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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