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Sponsored by: |
Assaf-Harofeh Medical Center |
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Information provided by: | Assaf-Harofeh Medical Center |
ClinicalTrials.gov Identifier: | NCT00645996 |
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:
Condition | Intervention |
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Immunity Measles Mumps Rubella |
Dietary Supplement: Probiotics (L.acidophilus and B.lactis) Dietary Supplement: Cornflor |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 100 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Dietary Supplement: Probiotics (L.acidophilus and B.lactis)
2.1 X 109 L.acidophilus and B.lactis
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2: Placebo Comparator
Cornflour
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Dietary Supplement: Cornflor
Cornflour 2 gram daily
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Ages Eligible for Study: | 9 Months to 14 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ilan Youngster, MD | 972-8-9779130 |
Israel | |
Assaf Harofeh Medical Center | Recruiting |
Zerifin, Israel | |
Principal Investigator: Ilan Youngster |
Principal Investigator: | Eran Kozer | Assaf Harofeh MC |
Principal Investigator: | Ilan Youngster, MD | Assaf Harofeh MC |
Responsible Party: | Assaf Harofeh Medical Center ( Ilan Youngster ) |
Study ID Numbers: | 20070567(101/07) |
Study First Received: | March 25, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00645996 History of Changes |
Health Authority: | Israel: Ministry of Health; Israel: Ethics Commission |
Probiotics vaccines Measles Mumps Rubella |
Virus Diseases Paramyxoviridae Infections Measles Acidophilus |
Rubella Togaviridae Infections Mumps |
Virus Diseases Rubivirus Infections RNA Virus Infections Paramyxoviridae Infections Morbillivirus Infections |
Measles Rubella Togaviridae Infections Mononegavirales Infections |