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Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

This study has been completed.
Sponsor:
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT01150253
First received: June 23, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  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:

Arms Assigned Interventions
Experimental: probiotic fermented milk Dietary Supplement: L. paracasei fermented milk
Placebo Comparator: placebo Dietary Supplement: L. paracasei fermented milk

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Nestlé

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT01150253     History of Changes
Other Study ID Numbers: 06.09.NRC
Study First Received: June 23, 2010
Last Updated: June 23, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013