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

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 Overview

• Status: Unknown
• Conditions: Measles; Rubella; Mumps; Immunity
• Intervention / Treatment: Dietary supplement: Probiotics (L.acidophilus and B.lactis); Dietary supplement: Cornflor

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zerifin, Israel
    • Recruiting
    • Assaf Harofeh Medical Center
    • Principal Investigator: Ilan Youngster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of vaccine-related adverse events in the study group compared to the placebo group.	1 year

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: Eran Kozer, Assaf Harofeh MC; Principal Investigator: Ilan Youngster, MD, Assaf Harofeh MC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Anticipated): July 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (Estimate): March 28, 2008

Study Record Updates

• Last Update Posted (Estimate): March 28, 2008
• Last Update Submitted That Met QC Criteria: March 26, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Probiotics; Measles; vaccines; Mumps; Rubella
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Togaviridae Infections; Rubivirus Infections; Measles; Rubella
• Other Study ID Numbers: 20070567(101/07)