Impact of a Novel Immune Modulating Dietary Supplement on House Dust Mite Induced Allergic Rhinoconjunctivitis

NCT04477382 | Completed

• 1 other identifier: ImTAEC1
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

A validated mobile Allergen exposure chamber (AEC) is used to expose qualified study participants suffering from house dust mite (HDM) induced allergic rhinoconjunctivitis. A maximum of four individuals are exposed at a time under standardized conditions with a mixture of allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae (each 50%, faeces and body allergens; doses of 250 μg/m3 air; 21°C, and 55% relative air moisture). After the first exposure, a dietary supplement lozenge, containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols, is taken twice daily for a period of 12 weeks, followed by the second exposure. A minimum of thirty persons are challenged with HDM allergen. After entering the chamber there is an acclimatization phase of 20 minutes with no exposure. Exposure time starts after acclimatization in the chamber and is 120 minutes at each visit. Objective parameters are recorded every 30 minutes, and subjective parameters are recorded every 10 minutes over a period of 120 minutes. During the exposure a plateau (steady-state) of total nasal symptom score with a difference from baseline is measured in all participants for each of the two exposures with HDM.

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 V3 (final 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 (11)

• 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 exposure until 120 minutes. An acclimatization phase of 20 minutes takes place in the chamber - so time point zero is when exposure starts after 20 minutes of acclimatization

Interventions

holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, is loaded with ligands such as retinoic acid, zinc and polyphenol-iron complexes. DIETARY_SUPPLEMENT

Subjects suffering from house dust mite (HDM) allergic rhinoconjunctivitis who are reacting positively to chamber exposure with HDM are reevaluated in the exposure chamber 3 months after taking food supplements.

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 group recruitment is based on an existing data base of subjects suffering from HDM-induced allergic rhinoconjunctivitis reacting positively to chamber exposure with HDM and by advertising for volunteers.

You may qualify if:

• Allergy to house dust mite (HDM) with rhinoconjunctivitis symptoms with/without asthma. These allergic symptoms must have been present for at least 2 years and severity assessed by anamnesis according to ARIA guidelines (mild; moderate/severe - Bousquet et al, 2007)
• Positive skin test to HDM extract using a skin testing diagnostic product used in the daily routines of the clinics, with a wheal diameter \> 3 mm
• Positive nasal provocation test to HDM allergen as used in the chamber and/or a history of TNSS ≥ 3 after 120 min HDM exposure in the chamber
• Oral and written informed consent

You may not qualify if:

• Current or previous treatment with allergy vaccination within the last two years.
• Concomitant (or newly developing during study period) severe disease interfering with allergy testing
• Co-medication interfering with allergy testing for other diseases, e.g. immunosuppressants, oral and/or nasal corticosteroids, chromones and pregnancy
• Clinically relevant co-sensitization to early blossoming tree pollen allergens, and cat allergens
• Patient with FEV1 \< 80% of predicted value prior to exposure
• Patients with severe asthma and / or with a history of uncontrolled asthmatic attacks in the last three months before the selection process
• Patients with an upper intestinal tract disease, where the local examiner believes that taking the dietary supplement could pose a risk to the patient
• History of serious chronic medical conditions and/or any disease where, in the opinion of the site investigator, participation in the trial would pose a risk for the patient
• Treatment prior to study visits and during the whole study time with:
• systemic corticosteroids within three weeks (21 days)
• topical nasal corticosteroids within two weeks (14 days)
• chromones within 7 days
• antihistamines within 72 hours before visit 1
• antibiotics within 3 months before visit 1 and during the whole study
• anti-allergic drugs during the whole study time.

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, Graessel A, Raab J, Banghard W, Krause L, Becker S, Kugler S, Zuberbier T, Ott V, Kramer MF, Roth-Walter F, Jensen-Jarolim E and Guethoff S. Targeted micronutrition via holo-BLG based on the farm effect in house dust mite allergic rhinoconjunctivitis patients - first evaluation in a standardized allergen exposure chamber. Allergo Journal International. 2021. doi:10.1007/s40629-021-00163-9.

  RESULT

MeSH Terms

Conditions

Dust Mite Allergy; Rhinitis, Allergic

Interventions

Lactoglobulins; Tretinoin; Zinc

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Sylvia Becker

  Managing Director, 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: July 8, 2020
• First Posted: July 20, 2020
• Study Start: January 6, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)