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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014