Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-28 @ 6:34 PM
Study NCT ID:
NCT01997606
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2013-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
House Dust Mite Allergen Reduction in Bedding: Purotex Impregnated Covers of Bekaert Textiles
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Cross-over Study of the Impact of Purotex Covers on the Concentration of House Dust Mite Allergen in Bedding and the Quality of Life in Patients With Allergic Rhinitis to House Dust Mite.
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Purotex covers
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: