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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified March 2008 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier:

NCT00645996

First received: March 25, 2008

Last updated: March 26, 2008

Last verified: March 2008

History of Changes

Purpose

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	Intervention
Immunity Measles Mumps Rubella	Dietary Supplement: Probiotics (L.acidophilus and B.lactis) Dietary Supplement: Cornflor


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Measles Mumps Rubella

Genetic and Rare Diseases Information Center resources: Rubella Measles

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645996

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


Responsible Party:	Ilan Youngster, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00645996 History of Changes
Other Study ID Numbers:	20070567(101/07)
Study First Received:	March 25, 2008
Last Updated:	March 26, 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

ClinicalTrials.gov processed this record on July 21, 2017

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