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CompletedNCT01233154Updated Mar 5, 2014

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

An interventional study of probiotic and probiotic in Allergic Rhinitis, sponsored by Société des Produits Nestlé (SPN). Completed at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-05.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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.

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Conditions studied

  • Allergic Rhinitis

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03

In context

Rhinitis, Allergic

1,042 studies on the registry are indexed under Rhinitis, Allergic; 91 are open to participants now.

This study's enrollment of 30 is below the median of 90 across 858 interventional studies indexed under Rhinitis, Allergic.

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Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    L. paracasei

    L. paracasei

    Dietary Supplement: probiotic

  • Experimental
    L. acidophilus + B. lactis

    L. acidophilus + B. lactis

    Dietary Supplement: probiotic

Interventions

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What researchers measure

Primary outcomes

  1. Nasal reaction threshold when provocation test with allergens

    Time frame: 4 weeks

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Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, 1011, Switzerland
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References and documents

Publications

  • 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. PubMed 24393277 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01233154
Responsible party
Sponsor
First posted
Nov 3, 2010
Start date
Oct 2007
Primary completion
Mar 2008
Completion
Jun 2008
Last update
Mar 5, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Probiotic

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