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Efficacy of Two HMOs in Chinese Infants
Sponsor: Société des Produits Nestlé (SPN)
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.
Official title: 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
Key Details
Gender
All
Age Range
3 Days - 14 Days
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2024-07-29
Completion Date
2027-06
Last Updated
2025-11-28
Healthy Volunteers
Yes
Conditions
Interventions
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).
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).
Locations (1)
The International Peace Maternity & Child Health Hospital of China Welfare Institute
Shanghai, China