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OpenTrials
Completed

NCT Number: NCT00948051

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

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.

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Key information

Conditions

Infant

Age range

4 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Tormo

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-on formula supplemented with fructo-oligosaccharides

Dietary Supplement

Follow-on formula supplemented with fructo-oligosaccharides

Follow-on formula enriched with placebo (maltodextrins)

Dietary Supplement

Follow-on formula enriched with placebo (maltodextrins)

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Syral

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2009
Registry last updated
Apr 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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