Status:
COMPLETED
Long-term Effect of a 3-month Supplementation With Holo-BLG 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
The aim of the study is to investigate the long-term effect of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in people with allergic rhinoconjunct...
Eligibility Criteria
Inclusion
- Participation in the predecessor study including complete intake of the holo-BLG lozenge for 3 months; inclusion in the final analysis set of the predecessor study
- patients with allergic rhinoconjunctivitis caused by house dust mites of any gender, aged 18-65 years
- Verbal and written informed consent
Exclusion
- Persons \<18 years
- lack of verbal and written consent
- persons who do not speak German
- seriously ill persons
- Persons with immunosuppressive medication such as systemic corticosteroids, cyclosporine
- Pregnancy and breastfeeding
- psychiatric illness
- Persons who have received or have started sublingual or subcutaneous immunotherapy (SLIT/SCIT) against house dust mites in the last 2 years before screening
- Contraindications and/or history of adrenaline intolerance and/or emergency medication.
- Concurrent use of anti-allergic medications and/or inadequate washout period of these anti-allergic medications prior to the selection process and exposure in the exposure chamber
- Use of an investigational drug 30 days/5 half-lives of the drug (whichever is longer) prior to screening
- Use of certain drugs prior to V5: Systemic corticosteroids within 3 weeks; Topical nasal corticosteroids within 2 weeks; Chromones within 7 days; Antihistamines within 72h; Antibiotics within 3 months; Pro-, Pre- and Synbiotics 1 month
Key Trial Info
Start Date :
January 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 12 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04872868
Start Date
January 27 2021
End Date
February 12 2021
Last Update
April 22 2022
Active Locations (1)
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1
ECARF Institute GmbH
Berlin, Germany, 10115