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The Anti-Allergic Effects of Specific Probiotics

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00480129
First received: May 25, 2007
Last updated: January 4, 2008
Last verified: January 2008
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Anti-Allergic Effects of Specific Probiotics - a Double Blind Clinical Study

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
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
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: 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00480129     History of Changes
Other Study ID Numbers: 12885
Study First Received: May 25, 2007
Last Updated: January 4, 2008
Health Authority: Canada: University of Western Ontario Health Science Research Ethics Board
Canada: Ontario Ministry of Agriculture, Food and Rural Affairs

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

Additional relevant MeSH terms:
Anti-Allergic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014