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Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01150253
First received: June 23, 2010
Last updated: January 13, 2014
Last verified: January 2014

June 23, 2010
January 13, 2014
August 2006
March 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01150253 on ClinicalTrials.gov Archive Site
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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

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.

Not Provided
Interventional
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Intervention Model: Crossover Assignment
Allergic Rhinitis
Dietary Supplement: L. paracasei fermented milk
  • Experimental: probiotic fermented milk
    Intervention: Dietary Supplement: L. paracasei fermented milk
  • Placebo Comparator: placebo
    Intervention: Dietary Supplement: L. paracasei fermented milk
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 35 Years
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Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01150253
06.09.NRC
No
Nestlé
Nestlé
Not Provided
Principal Investigator: François Spertini, Prof Centre Hospitalier Universitaire Vaudois
Nestlé
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP