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

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.

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Dust Mite Allergy

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10115
    • ECARF Institute GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PNIF	PNIF (peak nasal inspiration flow) liter/minute.	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
FEV1/FVC	Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.	Recorded at time zero (0) and 120 minutes
TESS	The Total Eye Symptom Score (TESS) is the sum of 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 9.	Up to 120 minutes following allergen challenge
TBSS	The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TBSS of 12.	Up to 120 minutes following allergen challenge
VAS	Visual Analogue Scale: Before, every 30 minutes during and after the exposure patients grade the question on their well-being by putting a vertical line on a 10 cm line representing severity from 0 cm "very good" to 10 cm "very bad".	Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
Adverse events with regards to the allergen exposure	Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure.	up to 24 hours after AEC exposure
TSS	Total Symptom Score in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V5 (follow-up AEC exposure). The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 3 eye symptoms (itchy eyes, watery eyes, and gritty feeling), 4 bronchial symptoms (wheezing, cough, breathlessness, and asthma), and 2 other symptoms (itchy palate, and itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TSS of 39.	Up to 120 minutes following allergen challenge
PEF	PEF (peak expiratory flow) liter/minute.	Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
FEV1	Forced expiratory volume in 1 second, before and after the exposure.	Recorded at time zero (0) and 120 minutes
rescue medication and/or emergency treatment	Need for rescue medication and/or emergency treatment	during and up to 24 hours after AEC exposure

Collaborators and Investigators

• Sponsor: Ecarf Institute GmbH
• Collaborators: Bencard Allergie GmbH
• Investigators: Study Director: Sylvia Becker, ECARF Institute GmbH

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: 014-P-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No