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.

NCT ID: NCT06475521

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 579 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-17
• Study Completion Date: 2027-12-31

Brief Summary

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.

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.

Conditions

Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Infant formula test group; Group that receives the test product.

Group Type: EXPERIMENTAL

Infant Formula

Intervention Type: OTHER

Test group

Arm 2

Infant formula control group; Group that receives a comparative control product.

Group Type: ACTIVE_COMPARATOR

Infant Formula

Intervention Type: OTHER

Test group

Interventions

Infant Formula

Test group

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Centre Asklepiy OOD Dupinista

Dupnitsa, , Bulgaria

Site Status: RECRUITING

Countries

Bulgaria

Central Contacts

Danone Nutricia Research

Role: CONTACT

register.clinicalresearchnutricia@danone.com

0302095000

Facility Contacts

Elza Erinina

Role: primary

mc.asklepii2014@gmail.com

+359894604527

Valentina Nikolova Dr.

Role: backup

Other Identifiers

SBB22R&56319

Identifier Type: -

Identifier Source: org_study_id