Clinical trial NCT04872868: Long-term Effect of a 3-month Supplementation With Holo-BLG on House Dust Mite Induced Allergic Rhinoconjunctivitis
Official title: Evaluation of the Long-term Effect of a 3-month Supplementation With Holo-BLG (Food for Special Medical Purposes) in People With Allergic Rhinoconjunctivitis Caused by House Dust Mites During Inhalation Exposure to Mite Allergen in an Exposure Chamber.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dust Mite Allergy
Allergic Rhinitis
Lead sponsor: Ecarf Institute GmbH
Sponsor class: OTHER
Collaborators: name: Bencard Allergie GmbH
First posted: 2021-05-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study participants must have been participated in the in the predecessor study (supplementation phase with holo-BLG) including complete intake of the holo-BLG lozenge for 3 months and must have been included in the final analysis set of the predecessor study

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.


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

Primary outcomes:
measure: TNSS
timeFrame: After 120 minutes of allergen challenge
Secondary outcomes:
measure: TSS
timeFrame: Up to 120 minutes following allergen challenge
measure: TESS
timeFrame: Up to 120 minutes following allergen challenge
measure: TBSS
timeFrame: Up to 120 minutes following allergen challenge
measure: VAS
timeFrame: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
measure: PNIF
timeFrame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
measure: PEF
timeFrame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
measure: FEV1
timeFrame: Recorded at time zero (0) and 120 minutes
measure: FEV1/FVC
timeFrame: Recorded at time zero (0) and 120 minutes
measure: rescue medication and/or emergency treatment
timeFrame: during and up to 24 hours after AEC exposure
measure: Adverse events with regards to the allergen exposure
timeFrame: up to 24 hours after AEC exposure
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: ECARF Institute GmbH
Study officials:
affiliation: Ecarf Institute GmbH
name: Sylvia Becker
role: STUDY_DIRECTOR
References:
citation: 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