NCT06475521

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.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 579 (estimated)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 0 Days – 14 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Infant Formula	Test group

Timeline

• Start date: 2024-07-17
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2024-06-26
• Last updated: 2026-03-23

Locations

2 sites across 2 countries: Bulgaria, Poland