The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
Information source: Assaf-Harofeh Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immunity; Measles; Mumps; Rubella
Intervention: Probiotics (L.acidophilus and B.lactis) (Dietary Supplement); Cornflor (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Assaf-Harofeh Medical Center Official(s) and/or principal investigator(s):
Eran Kozer, Principal Investigator, Affiliation: Assaf Harofeh MC
Ilan Youngster, MD, Principal Investigator, Affiliation: Assaf Harofeh MC
Overall contact:
Ilan Youngster, MD, Phone: 972-8-9779130
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.
Secondary outcome: The number of vaccine-related adverse events in the study group compared to the placebo group.
Eligibility
Minimum age: 9 Months.
Maximum age: 14 Months.
Gender(s): Both.
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.
Locations and Contacts
Ilan Youngster, MD, Phone: 972-8-9779130
Assaf Harofeh Medical Center, Zerifin, Israel; Recruiting
Ilan Youngster, Principal Investigator
Additional Information
Starting date: March 2008
Last updated: March 26, 2008
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