House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles

Last updated: September 23, 2016
Sponsor: University Hospital, Ghent
Overall Status: Completed

Phase

N/A

Condition

Allergies & Asthma

Nasal Obstruction

Common Cold

Treatment

N/A

Clinical Study ID

NCT01997606
2012/398
  • Ages 18-65
  • All Genders

Study Summary

Product information:

Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected for their ability to clean up house dust mite allergen along with other allergen types.

Study design:

  • Placebo-controlled: the effect of the Purotex impregnated mattress and pillow covers will be compared to untreated, classical bedding covers (placebo).

  • Cross-over design: There will be 2 'treatment' arms. One arm (Arm 1) in which the subjects will first use the Purotex impregnated covers (Set A=Purotex) during 2 months (=period A) and, after a wash out period of 1 month, the untreated covers (set B=placebo) during 2 months (=period B). In the second arm (Arm 2), the subjects will first use the untreated set (set A=placebo) and, after a wash out period the Purotex impregnated covers (set B=Purotex).

  • Randomized: The subjects will be randomly assigned to one of the 2 treatment arms.

  • Double blind: both the subjects and the investigators will not know to which treatment arm the subjects are assigned.

Study hypothesis:

We want to investigate:

  • if there is a reduced concentration of HDM allergen in Purotex covers compared to untreated covers in real life

  • if patients with allergic rhinitis to house dust mite use the Purotex covers, they experience an improvement of their quality of life and sleep, and an improvement of their allergic symptoms and global discomfort

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must be willing to give/sign informed consent

  • Subjects (male or female) must be at least 18 years old and maximum 65 years old atscreening

  • Clinical history of allergic rhinitis for at least 1 year

  • Positive skin prick test for D. Pteronyssinus ± D. Farinae

  • Positive nasal provocation test with the house-dust-mite allergen

  • Specific IgE: Unicap positive to D. Pteronyssinus (d1) and D. Farinae (d2) (> 0.7U/ml)

  • VAS score for global discomfort caused by nasal- or other allergic symptoms during theprevious 4 weeks ≥ 5.

  • The concentration of Der p1 in the dust collected from own bedding (mattress andpillow), measured by ELISA is above the detection limit (≥ 0.488 ng/ml).

Exclusion

Exclusion Criteria:

  • Patients sensitized to animals should not be included if they are symptomatic uponexposure and regularly exposed to animals: positive SPT to pets and pets at home

  • Patients with an allergy to tree pollen (symptoms during the season + positive skinprick test) should not be included

  • Subject pregnant or lactating

  • Completed allergen specific immunotherapy (SCIT or SLIT) with HDM within the last 5years

  • SCIT or SLIT during the study period

  • Regular use of oral corticosteroids for exacerbations of asthma

  • Daily use of oral corticosteroids

  • Daily use of cyclosporine or other immunosuppressant drugs

  • Regular use of antibiotics

  • History of anaphylactic reaction to an allergen

  • Severe general diseases (especially cardiopulmonary disease with reduced lungcapacity)

Study Design

Total Participants: 20
Study Start date:
November 01, 2013
Estimated Completion Date:
September 30, 2016

Connect with a study center

  • Ghent University Hospital

    Ghent, 9000
    Belgium

    Site Not Available

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