Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis

NCT ID: NCT04872868

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 27 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2021-02-12

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 rhinoconjunctivitis caused by house dust mites and the associated symptoms (symptom type and severity) during exposure to house dust mites in an Allergen Exposure Chamber (AEC).

In particular, the study aims to evaluate whether the improvements in symptoms of house dust mite-induced rhinoconjunctivitis observed after 3 months of supplementation with holo-BLG can still be detected 7 to 8 months after the last intake.

Conditions

Dust Mite Allergy; Allergic Rhinitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bencard Allergie GmbH

OTHER

Sponsor Role: collaborator

Ecarf Institute GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Becker

Role: STUDY_DIRECTOR

Ecarf Institute GmbH

Locations

ECARF Institute GmbH

Berlin, , Germany

Countries

Germany

References

Bergmann, KC., Raab, J., Krause, L. et al. Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients. Allergo J Int (2022). https://doi.org/10.1007/s40629-021-00197-z

Reference Type: RESULT

Other Identifiers

014-P-21

Identifier Type: -

Identifier Source: org_study_id