NCT03520764

To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants

A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Danone Nutricia · Industry
• Sex: All
• Age: 44 Days
• Healthy volunteers: Accepted

Summary

This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits. Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age. Safety, growth and tolerance parameters will be followed and collected throughout the study.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	New infant formula with synbiotics	Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.
DIETARY_SUPPLEMENT	Standard infant formula with prebiotics	Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.

Timeline

• Start date: 2018-04-03
• Primary completion: 2020-03-06
• Completion: 2020-11-09
• First posted: 2018-05-11
• Last updated: 2021-02-26

Locations

6 sites across 1 country: China