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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00645996
Other study ID # 20070567(101/07)
Secondary ID
Status Recruiting
Phase N/A
First received March 25, 2008
Last updated March 26, 2008
Start date March 2008
Est. completion date October 2009

Study information

Verified date March 2008
Source Assaf-Harofeh Medical Center
Contact Ilan Youngster, MD
Phone 972-8-9779130
Is FDA regulated No
Health authority Israel: Ministry of HealthIsrael: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Months to 14 Months
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Assaf Harofeh Medical Center Zerifin

Sponsors (1)

Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group. 1 year No
Secondary The number of vaccine-related adverse events in the study group compared to the placebo group. 1 year No
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