NCT07534735

Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial

Growth, Gut Health, Immune Function, and Sleep Status in Infants and Young Children Fed With Novel Infant Formula : A Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Biostime (Changsha) Nutrition Foods Limited · Industry
• Sex: All
• Age: 12 Months – 18 Months
• Healthy volunteers: Accepted

Summary

Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.

Conditions

• Infant Growth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Investigational Formula 1	The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals
DIETARY_SUPPLEMENT	Investigational Formula 2	The infant formula is provided in powdered form that provides the appropriate amount of protein, carbohydrates, fats, vitamins, and minerals

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: China