Effects of follow-on Formula Enriched on Short-chain Fructooligosaccharides (scFOS) on Immune Response in Healthy Infants
April 12, 2011 updated by: Syral
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain
- Dr Tormo
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 5 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Follow-on formula enriched with placebo (maltodextrins)
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Experimental: Fructo-oligosaccharides
|
Follow-on formula supplemented with fructo-oligosaccharides
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
July 27, 2009
First Submitted That Met QC Criteria
July 28, 2009
First Posted (Estimate)
July 29, 2009
Study Record Updates
Last Update Posted (Estimate)
April 13, 2011
Last Update Submitted That Met QC Criteria
April 12, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- FOS_FOF08
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.