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

Not Applicable

Completed

• Conditions: Infant
• Interventions: Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides; Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)

• Registration Number: NCT00948051
• Lead Sponsor: Syral

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-12
• Last Update Posted: 2011-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fructo-oligosaccharides	Follow-on formula supplemented with fructo-oligosaccharides	-
Placebo	Follow-on formula enriched with placebo (maltodextrins)	-

Primary Outcome Measures

Name	Time	Method
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination	1 month

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dr Tormo; 🇪🇸 Barcelona, Spain