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: - 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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Dietary Supplement: Probiotics (L.acidophilus and B.lactis)
  • 2.1 X 109 L.acidophilus and B.lactis
• Dietary Supplement: Cornflor
  • Cornflour 2 gram daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2
  • Cornflour

Primary Measures

• The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
  • Time Frame: 1 year
    Safety Issue?: No

Secondary Measures

• The number of vaccine-related adverse events in the study group compared to the placebo group.
  • Time Frame: 1 year
    Safety Issue?: No

Inclusion Criteria:

• Age: 9-11 months.
• 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 suffering from any chronic diseases / conditions resulting in immune depression.
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 9 Months

Maximum Age for this Clinical Trial: 14 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Assaf-Harofeh Medical Center

Overall Clinical Trial Officials and Contacts

Eran Kozer Principal Investigator Assaf Harofeh MC  

Overall Contact: Ilan Youngster, MD 972-8-9779130 

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645996

Study ID Number: 20070567(101/07)

ClinicalTrials.gov Identifier: NCT00645996

Health Authority: Israel: Ministry of Health