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RECRUITING
NCT06361719
NA

Efficacy of Two HMOs in Chinese Infants

Sponsor: Société des Produits Nestlé (SPN)

View on ClinicalTrials.gov

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

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).

Locations (1)

The International Peace Maternity & Child Health Hospital of China Welfare Institute

Shanghai, China