The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
NCT ID: NCT00645996
Last Updated: 2008-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2008-03-31
2009-10-31
Brief Summary
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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:
* To determine whether administration of probiotics during infancy influences antibody levels following the routine childhood vaccinations.
* To determine whether administration of probiotics during infancy influences the rate of adverse effects following the routine childhood vaccinations.
Potential Impact: Vaccines, alongside with the discovery of Penicillin, have been cited as the great public health successes of the 20th century. However, even in countries with maximal childhood immunization coverage, the protective effect is not optimal. For example, only 70% to 90% of children immunized against chickenpox are actually protected against the disease. If we succeed in raising these numbers, even by a single percent, it will have a huge impact on society.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Probiotics (L.acidophilus and B.lactis)
2.1 X 109 L.acidophilus and B.lactis
2
Cornflour
Cornflor
Cornflour 2 gram daily
Interventions
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Probiotics (L.acidophilus and B.lactis)
2.1 X 109 L.acidophilus and B.lactis
Cornflor
Cornflour 2 gram daily
Eligibility Criteria
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Inclusion Criteria
* Parent or guardian intending to follow the recommended immunization schedule in Israel.
* Parent or guardian possessing sufficient knowledge of the Hebrew language.
Exclusion Criteria
* Infants taking medications affecting the immune system.
* Infants with permanent invasive catheters.
* Infants born prematurely (prior to gestational week 35)
* Parent or guardian objecting to collection of blood sample at the end of study.
9 Months
14 Months
ALL
Yes
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf Harofeh Medical Center
Principal Investigators
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Eran Kozer
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofeh MC
Ilan Youngster, MD
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofeh MC
Locations
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Assaf Harofeh Medical Center
Ẕerifin, , Israel
Countries
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Central Contacts
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Ilan Youngster, MD
Role: CONTACT
Phone: 972-8-9779130
Other Identifiers
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20070567(101/07)
Identifier Type: -
Identifier Source: org_study_id