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

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. Identifier: NCT00645996
Recruitment Status : Unknown
Verified March 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Information provided by:
Assaf-Harofeh Medical Center

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%.


  • 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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Mumps Rubella

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
Dietary Supplement: Cornflor
Cornflour 2 gram daily

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 ]

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645996

Contact: Ilan Youngster, MD 972-8-9779130

Assaf Harofeh Medical Center Recruiting
Zerifin, Israel
Principal Investigator: Ilan Youngster         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Principal Investigator: Eran Kozer Assaf Harofeh MC
Principal Investigator: Ilan Youngster, MD Assaf Harofeh MC

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

Keywords provided by Assaf-Harofeh Medical Center:

Additional relevant MeSH terms:
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubivirus Infections
Togaviridae Infections