Clinical trial NCT00645996: The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immunity
Measles
Mumps
Rubella
Keywords: Probiotics
vaccines
Measles
Mumps
Rubella
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
timeFrame: 1 year
Secondary outcomes:
measure: The number of vaccine-related adverse events in the study group compared to the placebo group.
timeFrame: 1 year
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf Harofeh MC
name: Eran Kozer
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf Harofeh MC
name: Ilan Youngster, MD
role: PRINCIPAL_INVESTIGATOR
References: