Status:
COMPLETED
Impact of a Novel Immune Modulating Dietary Supplement on House Dust Mite Induced Allergic Rhinoconjunctivitis
Lead Sponsor:
Ecarf Institute GmbH
Collaborating Sponsors:
Bencard Allergie GmbH
Conditions:
Dust Mite Allergy
Allergic Rhinitis
Eligibility:
All Genders
18-65 years
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 individua...
Eligibility Criteria
Inclusion
- Allergy to house dust mite (HDM) with rhinoconjunctivitis symptoms with/without asthma. These allergic symptoms must have been present for at least 2 years and severity assessed by anamnesis according to ARIA guidelines (mild; moderate/severe - Bousquet et al, 2007)
- Positive skin test to HDM extract using a skin testing diagnostic product used in the daily routines of the clinics, with a wheal diameter \> 3 mm
- Positive nasal provocation test to HDM allergen as used in the chamber and/or a history of TNSS ≥ 3 after 120 min HDM exposure in the chamber
- Oral and written informed consent
Exclusion
- Current or previous treatment with allergy vaccination within the last two years.
- Concomitant (or newly developing during study period) severe disease interfering with allergy testing
- Co-medication interfering with allergy testing for other diseases, e.g. immunosuppressants, oral and/or nasal corticosteroids, chromones and pregnancy
- Clinically relevant co-sensitization to early blossoming tree pollen allergens, and cat allergens
- Patient with FEV1 \< 80% of predicted value prior to exposure
- Patients with severe asthma and / or with a history of uncontrolled asthmatic attacks in the last three months before the selection process
- Patients with an upper intestinal tract disease, where the local examiner believes that taking the dietary supplement could pose a risk to the patient
- History of serious chronic medical conditions and/or any disease where, in the opinion of the site investigator, participation in the trial would pose a risk for the patient
- Treatment prior to study visits and during the whole study time with:
- systemic corticosteroids within three weeks (21 days)
- topical nasal corticosteroids within two weeks (14 days)
- chromones within 7 days
- antihistamines within 72 hours before visit 1
- antibiotics within 3 months before visit 1 and during the whole study
- anti-allergic drugs during the whole study time.
Key Trial Info
Start Date :
January 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04477382
Start Date
January 6 2020
End Date
June 30 2020
Last Update
April 26 2021
Active Locations (1)
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1
ECARF Institute GmbH
Berlin, Germany, 10115