NCT00948051CompletedNot Applicable
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 enrollmentStarted: March 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 4 Months to 5 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Study Sites (1)
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