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

N

Nestlé

Status

Completed

Conditions

Allergic Rhinitis

Treatments

Dietary Supplement: probiotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT01233154
07.27.NRC

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups

L. paracasei
Experimental group
Description:
L. paracasei
Treatment:
Dietary Supplement: probiotic
Dietary Supplement: probiotic
L. acidophilus + B. lactis
Experimental group
Description:
L. acidophilus + B. lactis
Treatment:
Dietary Supplement: probiotic
Dietary Supplement: probiotic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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