Clinical trial NCT04477382: Impact of a Novel Immune Modulating Dietary Supplement on House Dust Mite Induced Allergic Rhinoconjunctivitis
Official title: A Prospective, Validation Study to Observe the Effect of House Dust Mite Exposure in an Allergen Exposure Chamber (AEC) Within Dust Mite Allergic Patients Taking an Immune Modulating Dietary Supplement
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: 2020-07-20
Enrollment: 38
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 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

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 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
measure: PEF
timeFrame: 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
measure: FEV1
timeFrame: Up to 120 minutes following allergen challenge
measure: FEV1/FVC
timeFrame: Up to 120 minutes following allergen challenge
measure: Need for rescue medication and/or emergency treatment
timeFrame: up to 24 hours after AEC exposure
measure: Adverse events with regard to the taken dietary supplement
timeFrame: up to 24 hours after the final 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: Managing Director, ECARF Institute GmbH
name: Sylvia Becker
role: STUDY_DIRECTOR
References:
citation: 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.