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Sponsored by: |
University of California, Davis |
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Information provided by: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00554736 |
This is a placebo controlled double-blind single center study initiated and sponsored by CALPIS, Inc., Japan, and CALPIS U.S.A., Inc., Torrance, CA.
The overall objective of this study is to establish the benefit of a bacterial product, Lactobacillus acidophilus strain L-92 (CALPIS U.S.A., Inc., Torrance, CA), in patients with allergic rhinitis.
Condition | Intervention | Phase |
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Hayfever |
Biological: Lactobacillus acidophilus L-92 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial of Lactobacillus Acidophilus L92 on Markers of Allergic Inflammation by Nasal Provocation With Grass Pollen |
Estimated Enrollment: | 100 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
In the first phase, subjects with a history of grass pollinosis, with positive skin tests to grass, will be studied out of season and will be randomized to active treatment for 4 months.
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Biological: Lactobacillus acidophilus L-92
Nasal challenge and acoustic rhinometry will be performed at the first study visit and again at the end of the 4-month supplement period. Standardized perennial ryegrass pollen extract (Lolium perenne) (Hollister-Stier, Inc., Spokane, WA) will be used. Dilutions of the standard product will be made in sterile saline prior to use. The standard product strength is 100,000 BAU/mL. Provocation will start with 100 BAU/mL, delivered as a 100 microliter puff into each nostril nose during breath holding, followed by expiration. Acoustic rhinometry, performed in each nostril, will be recorded at 15 minutes. A change of 30% from baseline in the composite score is considered significant. The dose will be increased every 20 minutes if there is no response. The concentrations used will be 100 BAU, 330 BAU, 1000 BAU, 3300 BAU, 10,000 BAU or 33,000 BAU/mL.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
History of nasal deviation
United States, California | |
University of California Davis Department of Dermatology | |
Sacramento, California, United States, 95816 |
Principal Investigator: | Fu-Tong Liu, M.D., Ph.D. | University of California, Davis |
Responsible Party: | University of California Davis ( Fu-Tong Liu,M.D., Ph.D. ) |
Study ID Numbers: | 200614299-2, 200614299-1 |
Study First Received: | November 5, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00554736 |
Health Authority: | United States: Institutional Review Board |
Pollen Allergy Allergy |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Diseases Rhinitis, Allergic, Seasonal |
Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity Inflammation |
Pathologic Processes Immune System Diseases Nose Diseases |