A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants

Syral1 site in 1 country60 target enrollmentMarch 2009

ConditionsInfant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant
Sponsor: Syral
Enrollment: 60
Locations: 1
Primary Endpoint: To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Syral

Eligibility Criteria

Inclusion Criteria

•infants aged of 4 months at randomization
•not breast-fed infants

Exclusion Criteria

•infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria
•infants suffering from a disease associated with gastro-intestinal disorder
•infants who have taken antibiotic during the 2 months preceding randomization

Outcomes

Primary Outcomes

To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination

Time Frame: 1 month

Secondary Outcomes

To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration(1 month)