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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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01150253     History of Changes
Other Study ID Numbers: 06.09.NRC
Study First Received: June 23, 2010
Last Updated: January 13, 2014
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 24, 2014