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Dust Mite AllergyNCT04477382

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

An observational study of Dust Mite Allergy and Allergic Rhinitis, run by Ecarf Institute GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Dust Mite Allergy, Allergic Rhinitis
What is being tested?
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.
How many people
38 participants
Where
1 siteGermany
Study dates
6 Jan 2020to 30 Jun 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • ECARF Institute GmbH

    Berlin, 10115

Other trials in Germany

About this study

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

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.

Being tested
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.
Medical subject headings
Dust Mite Allergy, Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: After 120 minutes of allergen challenge

Secondary outcomes (11)

  1. TSS

    Total Symptom Score in response to HDM exposure in an AEC at V1 (baseline AEC exposure) versus V3 (final 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.

    Measured: Up to 120 minutes following allergen challenge

  2. 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.

    Measured: Up to 120 minutes following allergen challenge

  3. 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.

    Measured: Up to 120 minutes following allergen challenge

  4. 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".

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

  5. PNIF

    PNIF (peak nasal inspiration flow) liter/minute.

    Measured: 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

  6. PEF

    PEF (peak expiratory flow) liter/minute.

    Measured: 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

  7. FEV1

    Forced expiratory volume in 1 second, before and after the exposure.

    Measured: Up to 120 minutes following allergen challenge

  8. FEV1/FVC

    Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.

    Measured: Up to 120 minutes following allergen challenge

  9. Need for rescue medication and/or emergency treatment

    Need for rescue medication and/or emergency treatment.

    Measured: up to 24 hours after AEC exposure

  10. Adverse events with regard to the taken dietary supplement

    Number of events and number of patients recording adverse events with regard to the taken dietary supplement. After completing the baseline AEC exposure at V1 the patients will enter the 3-month consumption period with the dietary supplement. Every patient will document potential AEs in the patient report form. In addition, the patient will be called every 4 weeks during the consumption period to follow up on potential AEs with the intake. The final safety phone call will be made 24 hours after the final AEC exposure.

    Measured: up to 24 hours after the final AEC exposure

  11. 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.

    Measured: up to 24 hours after AEC exposure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start6 Jan 2020
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477382
Sponsor's protocol ID
ImTAEC1
Status last verified
Mar 2021
First submitted
8 Jul 2020
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Dust Mite Allergy and Allergic Rhinitis, run by Ecarf Institute GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TNSS (time frame: After 120 minutes of allergen challenge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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