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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:
ClinicalTrials.gov Identifier:
NCT00645996
First Posted: March 28, 2008
Last Update Posted: March 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
March 25, 2008
March 28, 2008
March 28, 2008
March 2008
July 2009   (Final data collection date for primary outcome measure)
The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group. [ Time Frame: 1 year ]
Same as current
No Changes Posted
The number of vaccine-related adverse events in the study group compared to the placebo group. [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
The Influence of Probiotics on the Immunologic Response to Vaccinations in Infants
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Immunity
  • Measles
  • Mumps
  • Rubella
  • Dietary Supplement: Probiotics (L.acidophilus and B.lactis)
    2.1 X 109 L.acidophilus and B.lactis
  • Dietary Supplement: Cornflor
    Cornflour 2 gram daily
  • Experimental: 1
    Intervention: Dietary Supplement: Probiotics (L.acidophilus and B.lactis)
  • Placebo Comparator: 2
    Cornflour
    Intervention: Dietary Supplement: Cornflor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
October 2009
July 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
9 Months to 14 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00645996
20070567(101/07)
No
Not Provided
Not Provided
Ilan Youngster, Assaf Harofeh Medical Center
Assaf-Harofeh Medical Center
Not Provided
Principal Investigator: Eran Kozer Assaf Harofeh MC
Principal Investigator: Ilan Youngster, MD Assaf Harofeh MC
Assaf-Harofeh Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP