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Sponsor study identifier
interventional
100
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Background: It is well established that the presence of bacteria in the intestine has a profound influence on health. Probiotics, ("beneficial bacteria") have shown ameliorating effects on various infectious diseases. The influence of probiotics on several immune-mediated conditions has also been investigated, among them, atopic dermatitis ("Asthma of the skin"), and milk allergy. The precise mechanism of action of probiotics is not fully understood. Several animal and human studies have shown the probiotic bacteria to influence the immune system. The aim of the present study is to evaluate whether supplementing the diet with oral probiotics affects the immune response of children following routine vaccination against 4 common childhood viral diseases: Mumps, Measles, Rubella and Varicella. Objective(s) and Hypothesis(es): Hypothesis: Administration of probiotics will increase the amount of antibodies produced following vaccination for Measles, Mumps, Rubella and Varicella, by over 15%. Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
March 25, 2008
Actual (reported)March 28, 2008
Actual (reported)July 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
1 year
The number of vaccine-related adverse events in the study group compared to the placebo group.
1 year
Cornflour
2.1 X 109 L.acidophilus and B.lactis
Cornflour 2 gram daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Assaf Harofeh Medical Center
Ẕerifin, Israel
Eran Kozer
Assaf Harofeh MC
Ilan Youngster, MD
Assaf Harofeh MC
First Submitted
March 25, 2008
First Posted
March 28, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 28, 2008
Record last verified: 2008-03
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Source: ClinicalTrials.gov.
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