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Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01150253
First Posted: June 24, 2010
Last Update Posted: January 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
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.

Condition Intervention
Allergic Rhinitis Dietary Supplement: L. paracasei fermented milk

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Official Title: 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

Further study details as provided by Nestlé:

Study Start Date: August 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: probiotic fermented milk Dietary Supplement: L. paracasei fermented milk
Placebo Comparator: placebo Dietary Supplement: L. paracasei fermented milk

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
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): NCT01150253


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: François Spertini, Prof Centre Hospitalier Universitaire Vaudois
  More Information

Publications:
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01150253     History of Changes
Other Study ID Numbers: 06.09.NRC
First Submitted: June 23, 2010
First Posted: June 24, 2010
Last Update Posted: January 14, 2014
Last Verified: January 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