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)
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
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
Infant formula test group; Group that receives the test product.
|
Test group
|
|
Active Comparator: Arm 2
Infant formula control group; Group that receives a comparative control product.
|
Test group
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBB22R&56319
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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