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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00948051

Enrollment

Registered

2009-07-29

Start date

2009-03-31

Completion date

2010-12-31

Last updated

2011-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant

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.

Interventions

DIETARY_SUPPLEMENTFollow-on formula supplemented with fructo-oligosaccharides

Follow-on formula supplemented with fructo-oligosaccharides

DIETARY_SUPPLEMENTFollow-on formula enriched with placebo (maltodextrins)

Follow-on formula enriched with placebo (maltodextrins)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Months to 5 Months

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026