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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Study Start Date :	March 2008
Estimated Primary Completion Date :	July 2009
Estimated Study Completion Date :	October 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	9 Months to 14 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ilan Youngster, MD	972-8-9779130

Locations

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

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:	Eran Kozer	Assaf Harofeh MC
Principal Investigator:	Ilan Youngster, MD	Assaf Harofeh MC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ilan Youngster, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00645996 History of Changes
Other Study ID Numbers:	20070567(101/07)
First Posted:	March 28, 2008
Last Update Posted:	March 28, 2008
Last Verified:	March 2008

Keywords provided by Assaf-Harofeh Medical Center:

Probiotics; vaccines; Measles; Mumps; Rubella

Additional relevant MeSH terms:

Measles; Rubella; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections	RNA Virus Infections; Virus Diseases; Rubivirus Infections; Togaviridae Infections