NCT00645996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

March 25, 2008

Last Update Submit

March 26, 2008

Conditions

ImmunityMeaslesMumpsRubella

Keywords

ProbioticsvaccinesMeaslesMumpsRubella

Outcome Measures

Primary Outcomes (1)

  • The level of antibodies against Measles, Mumps, Rubella and Varicella in the study group compared to the placebo group.

    1 year

Secondary Outcomes (1)

  • The number of vaccine-related adverse events in the study group compared to the placebo group.

    1 year

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: Probiotics (L.acidophilus and B.lactis)

2

PLACEBO COMPARATOR

Cornflour

Dietary Supplement: Cornflor

Interventions

Probiotics (L.acidophilus and B.lactis)DIETARY_SUPPLEMENT

2.1 X 109 L.acidophilus and B.lactis

1
CornflorDIETARY_SUPPLEMENT

Cornflour 2 gram daily

2

Eligibility Criteria

Age9 Months - 14 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

MeaslesMumpsRubella

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae Infections

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Eran Kozer

    Assaf Harofeh MC

    PRINCIPAL INVESTIGATOR

  • Ilan Youngster, MD

    Assaf Harofeh MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Youngster, MD

CONTACT

972-8-9779130

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2009

Study Completion

October 1, 2009

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

IL(1)