ECARF Institute GmbH
Berlin, 10115, Germany
NCT Number: NCT05455749
The aim of the study is to investigate the antigen-unspecific effect of a 3 months supplementation with a food for special medical purposes (FSMP) in form of a lozenge containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols (holo-BLG) in patients with allergic rhinoconjunctivitis caused by cat (hair/dander) and the associated symptoms (symptom type and severity) during exposure to cat allergen in an Allergen Exposure Chamber (AEC).
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Berlin, 10115, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, loaded with ligands (vitamin A, zinc and polyphenol-iron complexes)
Time frame: After 120 minutes of allergen challenge
Total Symptom Score in response to cat exposure in an AEC at baseline versus final AEC exposure. The TSS is the sum of 4 nose symptoms (runny nose, sneezing, itchy nose, and blocked nose), 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening), 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus), 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 42.
Time frame: Up to 120 minutes following allergen challenge
The Total Nasal Symptom Score (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.
Time frame: Up to 120 minutes following allergen challenge
The Total Eye Symptom Score (TESS) is the sum of 4 eye symptoms (itchy eyes, watery eyes, gritty feeling, eye reddening) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TESS of 12.
Time frame: Up to 120 minutes following allergen challenge
The Total Bronchial Symptom Score (TBSS) is the sum of 4 bronchial symptoms (wheezing, cough, breathlessness, rhonchus) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TBSS of 12.
Time frame: Recorded at time zero (0) and every 30 minutes during exposure until 120 minutes
Visual Analogue Scale: Before, every 30 minutes during and after each 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".
Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
PNIF (peak nasal inspiration flow) liter/minute.
Time frame: Recorded at time zero (0) and every 30 minutes during allergen exposure up to 120 minutes
PEF (peak expiratory flow) liter/minute
Time frame: Recorded at time zero (0) and 120 minutes
Forced expiratory volume in 1 second, before and after the exposure
Time frame: Recorded at time zero (0) and 120 minutes
Forced expiratory volume in 1 second/forced vital capacity ratio, before and after the exposure.
Time frame: up to 24 hours after AEC exposure
Number of events and number of patients recording late-phase reactions and/or adverse events with regards to the allergen exposure
Time frame: up to 3 months following first AEC
Changes in Nasal Provocation Test before and after intervention period
Time frame: Up to 120 minutes following allergen challenge
The Total Other Symptom Score (TBSS) is the sum of 2 additional symptoms (itchy palate, itchy skin) on a scale of 0 to 3 (no symptoms, mild symptoms, moderate symptoms, and severe symptoms), leading to a maximum TOSS of 6.
Allergy Therapeutics
Industry
A Prospective Pilot Study to Observe the Effects of Cat Exposure in an Allergen Exposure Chamber (AEC) in Cat Allergic Patients Taking a Food for Special Medical Purposes (holoBLG) for 3 Months
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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