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

NCT ID: NCT00948051

Last Updated: 2011-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fructo-oligosaccharides

Group Type EXPERIMENTAL

Follow-on formula supplemented with fructo-oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Follow-on formula supplemented with fructo-oligosaccharides

Placebo

Group Type PLACEBO_COMPARATOR

Follow-on formula enriched with placebo (maltodextrins)

Intervention Type DIETARY_SUPPLEMENT

Follow-on formula enriched with placebo (maltodextrins)

Interventions

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Follow-on formula supplemented with fructo-oligosaccharides

Follow-on formula supplemented with fructo-oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

Follow-on formula enriched with placebo (maltodextrins)

Follow-on formula enriched with placebo (maltodextrins)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

4 Months

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Syral

INDUSTRY

Sponsor Role lead

Responsible Party

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Syral

Locations

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Dr Tormo

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FOS_FOF08

Identifier Type: -

Identifier Source: org_study_id

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