The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
Primary Purpose
Immunity, Measles, Mumps
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Probiotics (L.acidophilus and B.lactis)
Cornflor
Sponsored by
About this trial
This is an interventional prevention trial for Immunity focused on measuring Probiotics, vaccines, Measles, Mumps, Rubella
Eligibility 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.
Sites / Locations
- Assaf Harofeh Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Cornflour
Outcomes
Primary Outcome Measures
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
Secondary Outcome Measures
The number of vaccine-related adverse events in the study group compared to the placebo group.
Full Information
NCT ID
NCT00645996
First Posted
March 25, 2008
Last Updated
March 26, 2008
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00645996
Brief Title
The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity, Measles, Mumps, Rubella
Keywords
Probiotics, vaccines, Measles, Mumps, Rubella
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Cornflour
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics (L.acidophilus and B.lactis)
Intervention Description
2.1 X 109 L.acidophilus and B.lactis
Intervention Type
Dietary Supplement
Intervention Name(s)
Cornflor
Intervention Description
Cornflour 2 gram daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The number of vaccine-related adverse events in the study group compared to the placebo group.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Youngster, MD
Phone
972-8-9779130
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Kozer
Organizational Affiliation
Assaf Harofeh MC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilan Youngster, MD
Organizational Affiliation
Assaf Harofeh MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Youngster
12. IPD Sharing Statement
Learn more about this trial
The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
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