Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients

Study Purpose

Cat allergy is the most common animal allergy, affecting approximately 1 in 5 adults worldwide. The prevalence of allergy to furry animals is increasing, and cat allergy is a major risk factor for the development of asthma and rhinitis. Fel-d1 is the major feline allergen, to which 95% of cat allergic people react. All cats produce Fel-d1 regardless of breed, age, coat type, sex or weight. Fel-d1 is contained primarily in the saliva and sebum of cats. This allergy manifests itself as allergic rhinitis (AR) (sneezing, cold, coughing, conjunctivitis with watering and itching), severe asthma, and irritation and swelling of the skin when scratched. A new approach to managing cat allergies is to neutralize the allergens at the source by feeding domestic cats a diet containing anti-Fel-d1 IgY antibodies. The purpose of this pilot study is to determine whether feeding domestic cats a food containing an egg product with anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®) induces a reduction of allergic symptoms in their owners.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Uncontrolled allergic rhinitis (with or without treatment) - Persistent allergic rhinitis with worsening of symptoms upon exposure to cats.

- Presence of one or two cats in the household, whose diet consists mainly of dry kibble.

- Agreement of the patient to change the food of the cat(s) and to feed it exclusively with the test kibbles during the study.

- Diagnosis of cat allergy defined by a positive prick test to standardized cat allergen or cat-specific IgE.

- Absence of allergy to pollens emitted in the region during the 4 months following the inclusion date, confirmed by a negative skin test.

- Person owning an android and/or IOS smartphone and having the possibility to connect to the internet (via phone subscription or WIFI connection), - Person who agrees to install the MASK-air application (medical device) on his personal smartphone, - Person having read and understood the information note and having signed their participation agreement before any specific procedure of the study.

Exclusion Criteria:

- Person planning to be away from the cat(s) for more than one week/month in the 4 months following the inclusion visit.

- Patient who has had a new cat in the home for less than one month.

- Patient in regular contact with other animals to which they are allergic.

- Patient with uncontrolled asthma.

- Patient receiving immunotherapy for cat allergies.

- Patient participating or having participated in an allergic rhinitis study within the last 30 days or 5 half-lives of study medication.

- Person who has difficulty understanding or reading the information.

- Person declaring to be under guardianship, curatorship or safeguard of justice.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05656482
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MASK-air SAS
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Nan Pham-Thi, Dr
Principal Investigator Affiliation	Allergologist
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rhinitis, Allergic

Contact a Trial Team

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International Sites

Cabinet médical Lion de Raspail, Paris, France

Status

Recruiting

Address

Cabinet médical Lion de Raspail

Paris, , 75014

Site Contact

Pham-Thi Nan, Dr

[email protected]

+33 6 08 82 81 47

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