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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948051
First Posted: July 29, 2009
Last Update Posted: April 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Syral
  Purpose
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.

Condition Intervention
Infant Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official 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

Further study details as provided by Syral:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fructo-oligosaccharides Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides
Follow-on formula supplemented with fructo-oligosaccharides
Placebo Comparator: Placebo Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins)
Follow-on formula enriched with placebo (maltodextrins)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948051


Locations
Spain
Dr Tormo
Barcelona, Spain
Sponsors and Collaborators
Syral
  More Information

Responsible Party: Frederique Respondek/ Scientific Affairs Manager, Syral
ClinicalTrials.gov Identifier: NCT00948051     History of Changes
Other Study ID Numbers: FOS_FOF08
First Submitted: July 27, 2009
First Posted: July 29, 2009
Last Update Posted: April 13, 2011
Last Verified: April 2011