MedTrace Logo

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

NCT00645996 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-03-28

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotics (L.acidophilus and B.lactis)

2.1 X 109 L.acidophilus and B.lactis

DIETARY_SUPPLEMENT

Cornflor

Cornflour 2 gram daily

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Eran Kozer · Assaf Harofeh MC

  • Ilan Youngster, MD · Assaf Harofeh MC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
14 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-07-31
Completion
2009-10-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00645996 on ClinicalTrials.gov