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Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects

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ClinicalTrials.gov Identifier: NCT01233154
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
Various studies in animal 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 L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Dietary Supplement: probiotic Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Experimental: L. paracasei
L. paracasei
Dietary Supplement: probiotic
Experimental: L. acidophilus + B. lactis
L. acidophilus + B. lactis
Dietary Supplement: probiotic



Primary Outcome Measures :
  1. Nasal reaction threshold when provocation test with allergens [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-40 years old
  • history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter > 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold <= 10000 standardized quality units/ml 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233154


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Nestlé

Publications of Results:
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01233154     History of Changes
Other Study ID Numbers: 07.27.NRC
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases