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

NCT04872868 | Completed

• 1 other identifier: 014-P-21
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• TNSS

  Total Nasal Symptom Score (TNSS) in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The TNSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TNSS of 12.

  After 120 minutes of allergen challenge

Secondary Outcomes (10)

• TSS

  Up to 120 minutes following allergen challenge

• TESS

  Up to 120 minutes following allergen challenge

• TBSS

  Up to 120 minutes following allergen challenge

• VAS

  Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes

• PNIF

  Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• patients with allergic rhinoconjunctivitis caused by house dust mites of any gender, aged 18-65 years
• Verbal and written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ecarf Institute GmbH: lead
• Bencard Allergie GmbH: collaborator

Study Sites (1)

ECARF Institute GmbH

Berlin, 10115, Germany

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Dust Mite Allergy; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sylvia Becker

  Ecarf Institute GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 5, 2021
• Study Start: January 27, 2021
• Primary Completion: February 12, 2021
• Study Completion: February 12, 2021
• Last Updated: April 22, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)