Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04477382
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2020-07-08
Brief Title:
Impact of a Novel Immune Modulating Dietary Supplement on House Dust Mite Induced Allergic Rhinoconjunctivitis
Sponsor:
Ecarf Institute GmbH
Organization:
Ecarf Institute GmbH
Study Overview
Official Title:
A Prospective Validation Study to Observe the Effect of House Dust Mite Exposure in an Allergen Exposure Chamber AEC Within Dust Mite Allergic Patients Taking an Immune Modulating Dietary Supplement
Status:
COMPLETED
Status Verified Date:
2021-03
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:
None
Brief Summary:
A validated mobile Allergen exposure chamber AEC is used to expose qualified study participants suffering from house dust mite HDM induced allergic rhinoconjunctivitis A maximum of four individuals are exposed at a time under standardized conditions with a mixture of allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae each 50 faeces and body allergens doses of 250 μgm3 air 21C and 55 relative air moisture After the first exposure a dietary supplement lozenge containing beta-lactoglobulin BLG iron retinoic acid zinc and polyphenols is taken twice daily for a period of 12 weeks followed by the second exposure A minimum of thirty persons are challenged with HDM allergen After entering the chamber there is an acclimatization phase of 20 minutes with no exposure Exposure time starts after acclimatization in the chamber and is 120 minutes at each visit Objective parameters are recorded every 30 minutes and subjective parameters are recorded every 10 minutes over a period of 120 minutes During the exposure a plateau steady-state of total nasal symptom score with a difference from baseline is measured in all participants for each of the two exposures with HDM
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None