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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
probiotic
probiotic
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

L. paracasei

L. acidophilus + B. lactis

Arm Description

L. paracasei

L. acidophilus + B. lactis

Outcomes

Primary Outcome Measures

Nasal reaction threshold when provocation test with allergens

Secondary Outcome Measures

Full Information

First Posted
November 2, 2010
Last Updated
March 4, 2014
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01233154
Brief Title
Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L. paracasei
Arm Type
Experimental
Arm Description
L. paracasei
Arm Title
L. acidophilus + B. lactis
Arm Type
Experimental
Arm Description
L. acidophilus + B. lactis
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic
Primary Outcome Measure Information:
Title
Nasal reaction threshold when provocation test with allergens
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24393277
Citation
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.
Results Reference
result

Learn more about this trial

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

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