The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00645996

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immunity Measles Mumps Rubella	Dietary Supplement: Probiotics (L.acidophilus and B.lactis) Dietary Supplement: Cornflor	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Mar 1, 2008

Anticipated Primary Completion Date :

Jul 1, 2009

Anticipated Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Dietary Supplement: Probiotics (L.acidophilus and B.lactis) 2.1 X 109 L.acidophilus and B.lactis
Placebo Comparator: 2 Cornflour	Dietary Supplement: Cornflor Cornflour 2 gram daily

Arm

Intervention/Treatment

Experimental: 1

Dietary Supplement: Probiotics (L.acidophilus and B.lactis)

2.1 X 109 L.acidophilus and B.lactis

Placebo Comparator: 2

Cornflour

Dietary Supplement: Cornflor

Cornflour 2 gram daily

Outcome Measures

Primary Outcome Measures

The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group. [1 year]

Secondary Outcome Measures

The number of vaccine-related adverse events in the study group compared to the placebo group. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 14 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.