The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
Recruitment status was: Recruiting
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%.
- 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.
|Immunity Measles Mumps Rubella||Dietary Supplement: Probiotics (L.acidophilus and B.lactis) Dietary Supplement: Cornflor|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
- The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group. [ Time Frame: 1 year ]
- The number of vaccine-related adverse events in the study group compared to the placebo group. [ Time Frame: 1 year ]
|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)|
Dietary Supplement: Probiotics (L.acidophilus and B.lactis)
2.1 X 109 L.acidophilus and B.lactis
Placebo Comparator: 2
Dietary Supplement: Cornflor
Cornflour 2 gram daily
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645996
|Contact: Ilan Youngster, MD||972-8-9779130|
|Assaf Harofeh Medical Center||Recruiting|
|Principal Investigator: Ilan Youngster|
|Principal Investigator:||Eran Kozer||Assaf Harofeh MC|
|Principal Investigator:||Ilan Youngster, MD||Assaf Harofeh MC|