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

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of vaccine-related adverse events in the study group compared to the placebo group. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Israel: Ministry of Health
Israel: Ethics Commission

Keywords provided by Assaf-Harofeh Medical Center:
Probiotics
vaccines
Measles
Mumps
Rubella

Additional relevant MeSH terms:
Measles
Mumps
Rubella
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on August 28, 2014