Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects
Double Blind Randomised Comparison of Two Preparations, One Enriched in Probiotics and One Without Probiotics (Placebo) in Grass Pollen Allergic Rhinitis Patients, Using a Nasal Provocation Test
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Various studies in animals and humans have shown a potential beneficial effect of probiotics consumption on allergy. However, few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a Lactobacillus paracasei on a nasal provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study, based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological parameters are compared between the two treatment periods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2010
CompletedFirst Posted
Study publicly available on registry
June 24, 2010
CompletedJanuary 14, 2014
January 1, 2014
7 months
June 23, 2010
January 13, 2014
Conditions
Study Arms (2)
probiotic fermented milk
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age 18 to 35 years
- history of allergic rhinitis to grass pollen confirmed by either a positive skin prick test (wheal diameter \>3 mm) or specific IgE for grass pollen (\>0.35 kU/L) as titrated by UniCAP 100 (Pharmacia Diagnostics, Uppsala, Sweden) and no history of perennial rhinitis
- a nasal reaction threshold of 10'000 standardized quality units (SQs)/ml grass pollen or less at the screening phase
You may not qualify if:
- any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
- uncontrolled asthma (peak expiratory flow \<20% of volunteer's best personal value)
- treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Related Publications (1)
Wassenberg J, Nutten S, Audran R, Barbier N, Aubert V, Moulin J, Mercenier A, Spertini F. Effect of Lactobacillus paracasei ST11 on a nasal provocation test with grass pollen in allergic rhinitis. Clin Exp Allergy. 2011 Apr;41(4):565-73. doi: 10.1111/j.1365-2222.2011.03695.x.
PMID: 21395878RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François Spertini, Prof
Centre Hospitalier Universitaire Vaudois
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2010
First Posted
June 24, 2010
Study Start
August 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
January 14, 2014
Record last verified: 2014-01