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

Syral

Status: Completed

Conditions: Infant

Treatments: Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins); Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides

Study type: Interventional

Funder types: Industry

Identifiers

NCT00948051

FOS_FOF08

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 4 to 5 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 2 patient groups, including a placebo group

Fructo-oligosaccharides

Experimental group

Treatment:

Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)