NCT04042454

To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation

A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Nutricia Research · Industry
• Sex: All
• Age: 3 Weeks – 9 Weeks
• Healthy volunteers: Accepted

Summary

A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)

Conditions

• Regurgitation, Gastric
• Diarrhea

Interventions

Type	Name	Description
OTHER	milk based anti-regurgitation infant formula	Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
OTHER	Milk based infant formula	Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.

Timeline

• Start date: 2019-12-10
• Primary completion: 2023-05-23
• Completion: 2023-05-23
• First posted: 2019-08-02
• Last updated: 2023-07-13

Locations

16 sites across 3 countries: Italy, Poland, Ukraine