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

This study has been completed.
Sponsor:
Information provided by:
Syral
ClinicalTrials.gov Identifier:
NCT00948051
First received: July 27, 2009
Last updated: April 12, 2011
Last verified: April 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   4 Months to 5 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948051

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

No publications provided

Responsible Party: Frederique Respondek/ Scientific Affairs Manager, Syral
ClinicalTrials.gov Identifier: NCT00948051     History of Changes
Other Study ID Numbers: FOS_FOF08
Study First Received: July 27, 2009
Last Updated: April 12, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on April 16, 2014