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

NCT01997606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-09-26

No results posted yet for this 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

Conditions

  • Allergic Rhinitis

Interventions

OTHER

use of Purotex treated bedding covers

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. The active probiotics are placed inside of millions of capsules and are introduced during the textile production. These human friendly bacteria remain non-active until friction force is created between the mattress/pillow and the sleeper's body. Under the friction force a small part of the capsules is opened and probiotics become active. They saturate the bacterial capacity of the textile and by doing so, reduce the risk of dust mite allergen development and growth of molds and harmful bacteria. The patients will apply the covers around their mattress and around their pillow. On top of these covers the patients will apply their own fitted sheet and pillowcase (which they will change every 4 weeks).

OTHER

placebo

Sponsors & Collaborators

  • Bekaert textiles NV Waregem

    collaborator UNKNOWN

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01997606 on ClinicalTrials.gov