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The Anti-allergic Effects of Specific Probiotics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480129
First Posted: May 30, 2007
Last Update Posted: August 11, 2015
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.
Collaborator:
Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by (Responsible Party):
Gregor Reid, Lawson Health Research Institute
  Purpose
We hypothesize that specifically selected probiotics can alleviate symptoms of allergy in lactose tolerant individuals. Two strains of probiotics, Lactobacillus rhamnosus GR-1, and Bifidobacterium adolescentis 7007-05 will be used to create a yogurt product. Additionally a non-probiotic yogurt product will also be made as a placebo. Allergy sufferers will be asked to consume one of the two types of yogurts (blinded) for two months. During the two months there will be 3 sampling days, for blood samples and nasal lavage samples. Additionally Mini Rhinoconjunctivitis Quality of Life Questionnaires will be filled out weekly over the two months. After the two months of perceived responses as well sample analysis we should have a better idea of how these specific probiotic effect the immune system and allergies.

Condition Intervention Phase
Allergic Rhinitis Behavioral: Probiotic or placebo yogurt consumed daily Device: Mini Rhinoconjunctivitis Quality of Life Questionnaire Procedure: Blood sample Procedure: Nasal lavage Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
Official Title: The Anti-allergic Effects of Specific Probiotics - a Double Blind Clinical Study

Further study details as provided by Gregor Reid, Lawson Health Research Institute:

Primary Outcome Measures:
  • Inflammatory versus anti-inflammatory serum cytokine fluctuations [ Time Frame: 2 months ]
  • Allergen specific IgE fluctuations [ Time Frame: 2 months ]
  • Type 2 T helper cell to Type 1 T helper cell ratios [ Time Frame: 2 months ]
  • T regulatory cell production of interleukin-10 [ Time Frame: 2 months ]
  • Cell count and type fluctuations in nasal lavage samples [ Time Frame: 2 months ]
  • Protein concentration fluctuations in nasal lavage samples [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Mini Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: 2 months ]

Enrollment: 36
Study Start Date: May 2007
Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of allergic rhinitis based on sneeze attacks, runny/blocked/itchy nose in the absence of a common cold during the previous 12 months.
  • History of positive skin prick test or blood radio-allergosorbent test (RAST) to grass and/or ragweed pollen

Exclusion Criteria:

  • Ongoing allergen immunotherapy
  • upper respiratory tract infection
  • Pregnancy
  • Clinical history of lactose-intolerance or allergies to cow-milk
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00480129


Locations
Canada, Ontario
Lawson Health Research Institute - Canadian Research and Development Centre for Probiotics
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Ontario Ministry of Agriculture, Food and Rural Affairs
Investigators
Principal Investigator: Gregor Reid, PhD Lawson Health Research Institute - Canadian Research and Development Centre for Probiotics
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregor Reid, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00480129     History of Changes
Other Study ID Numbers: 12885
First Submitted: May 25, 2007
First Posted: May 30, 2007
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Gregor Reid, Lawson Health Research Institute:
grass allergies,
ragweed allergies,
probiotics, lactobacillus,
bifidobacterium,
functional foods,
yogurt,
inflammatory cytokines

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Allergic Agents