Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150253
• Other study ID #: 06.09.NRC
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: January 13, 2014
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Intervention Model: Crossover Assignment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Dietary Supplement:
• L. paracasei fermented milk

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Wassenberg J, Nutten S, Audran R, Barbier N, Aubert V, Moulin J, Mercenier A, Spertini F. Effect of Lactobacillus paracasei ST11 on a nasal provocation test with grass pollen in allergic rhinitis. Clin Exp Allergy. 2011 Apr;41(4):565-73. doi: 10.1111/j.13 — View Citation