Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants

Syral60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Infant

Interventions

Follow-on formula supplemented with fructo-oligosaccharidesDIETARY_SUPPLEMENT

Follow-on formula supplemented with fructo-oligosaccharides

Follow-on formula enriched with placebo (maltodextrins)DIETARY_SUPPLEMENT

Follow-on formula enriched with placebo (maltodextrins)

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 5 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr Tormo

Barcelona, Spain

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

Time frame: 1 month

Data from ClinicalTrials.gov

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