Allergic Rhinitis Clinical Trial
Official title:
The Anti-allergic Effects of Specific Probiotics - a Double Blind Clinical Study
NCT number | NCT00480129 |
Other study ID # | 12885 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 2007 |
Est. completion date | October 2007 |
Verified date | August 2021 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | October 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 66 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Lawson Health Research Institute - Canadian Research and Development Centre for Probiotics | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | Ontario Ministry of Agriculture, Food and Rural Affairs |
Canada,
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Bruzzese E, Raia V, Gaudiello G, Polito G, Buccigrossi V, Formicola V, Guarino A. Intestinal inflammation is a frequent feature of cystic fibrosis and is reduced by probiotic administration. Aliment Pharmacol Ther. 2004 Oct 1;20(7):813-9. — View Citation
Isolauri E, Arvola T, Sütas Y, Moilanen E, Salminen S. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000 Nov;30(11):1604-10. — View Citation
Kalliomäki M, Salminen S, Arvilommi H, Kero P, Koskinen P, Isolauri E. Probiotics in primary prevention of atopic disease: a randomised placebo-controlled trial. Lancet. 2001 Apr 7;357(9262):1076-9. — View Citation
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Ogawa T, Hashikawa S, Asai Y, Sakamoto H, Yasuda K, Makimura Y. A new synbiotic, Lactobacillus casei subsp. casei together with dextran, reduces murine and human allergic reaction. FEMS Immunol Med Microbiol. 2006 Apr;46(3):400-9. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory versus anti-inflammatory serum cytokine fluctuations | 2 months | ||
Primary | Allergen specific IgE fluctuations | 2 months | ||
Primary | Type 2 T helper cell to Type 1 T helper cell ratios | 2 months | ||
Primary | T regulatory cell production of interleukin-10 | 2 months | ||
Primary | Cell count and type fluctuations in nasal lavage samples | 2 months | ||
Primary | Protein concentration fluctuations in nasal lavage samples | 2 months | ||
Secondary | Mini Rhinoconjunctivitis Quality of Life Questionnaire | 2 months |
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