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

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ClinicalTrials.gov Identifier: NCT00948051
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : April 13, 2011
Sponsor:
Information provided by:
Syral

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.

Condition or disease Intervention/treatment Phase
Infant Dietary Supplement: Follow-on formula supplemented with fructo-oligosaccharides Dietary Supplement: Follow-on formula enriched with placebo (maltodextrins) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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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

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

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