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

Not Applicable

Completed

• Conditions: Allergic Rhinitis
• Interventions: Dietary Supplement: probiotic

• Registration Number: NCT01233154
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-03
• Study Completion: 2008-06
• Study First Submitted: 2010-11-02
• Study First Submitted QC: 2010-11-02
• Study First Posted: 2010-11-03
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
L. paracasei	probiotic	L. paracasei
L. acidophilus + B. lactis	probiotic	L. acidophilus + B. lactis

Primary Outcome Measures

Name	Time	Method
Nasal reaction threshold when provocation test with allergens	4 weeks

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland