NCT06361719

Efficacy of Two HMOs in Chinese Infants

Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 3 Days – 14 Days
• Healthy volunteers: Accepted

Summary

This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
OTHER	Experimental Group (EG)	Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
OTHER	Control Group (CG)	Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).

Timeline

• Start date: 2024-07-29
• Primary completion: 2026-11-01
• Completion: 2027-06-01
• First posted: 2024-04-12
• Last updated: 2025-11-28

Locations

1 site across 1 country: China