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

NCT01233154 | Completed

• 1 other identifier: 07.27.NRC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Nasal reaction threshold when provocation test with allergens

  4 weeks

Study Arms (2)

L. paracasei

EXPERIMENTAL

L. paracasei

Dietary Supplement: probiotic

L. acidophilus + B. lactis

EXPERIMENTAL

L. acidophilus + B. lactis

Dietary Supplement: probiotic

Interventions

probiotic DIETARY_SUPPLEMENT

L. paracasei

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• Perrin Y, Nutten S, Audran R, Berger B, Bibiloni R, Wassenberg J, Barbier N, Aubert V, Moulin J, Singh A, Magliola C, Mercenier A, Spertini F. Comparison of two oral probiotic preparations in a randomized crossover trial highlights a potentially beneficial effect of Lactobacillus paracasei NCC2461 in patients with allergic rhinitis. Clin Transl Allergy. 2014 Jan 6;4(1):1. doi: 10.1186/2045-7022-4-1.

  PMID: 24393277 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

CH (1)