CompletedNCT00948051Updated Apr 13, 2011

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

An interventional study of Follow-on formula supplemented with fructo-oligosaccharides and Follow-on formula enriched with placebo (maltodextrins) in Infant, sponsored by Syral. Completed at 1 site in Spain. Open to participants aged 4 Months to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-04-13.

Sponsored by Syral · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 4 Months to 5 Months
Sex: All

Study 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.

Conditions studied

Infant

In context

Lead sponsor

Syral is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Months to 5 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

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Inclusion criteria

infants aged of 4 months at randomization
not breast-fed infants

Exclusion criteria

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

Phase: Not applicable
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 60 participants (estimated)

Study arms

Experimental
Fructo-oligosaccharides
Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides
Placebo comparator
Placebo
Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)

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)

What researchers measure

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

Study locations

1 site

Dr Tormo
Barcelona, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 13, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00948051
Lead sponsor: Syral
First posted: Jul 29, 2009
Start date: Mar 2009
Primary completion: Dec 2010
Completion: Dec 2010
Last update: Apr 13, 2011

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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