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

NCT ID: NCT05656482

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-06

Study Completion Date

2023-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Rhinitis, Allergic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cats fed with PRO PLAN® LIVECLEAT®

Patient with domestic cats fed with an egg product containing anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MASK-air SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nan Pham-Thi, Dr

Role: PRINCIPAL_INVESTIGATOR

Allergologist

Locations

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Cabinet médical Lion de Raspail

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Batot Géraldine, PhD

Role: CONTACT

+33 6 08 82 81 47

Facility Contacts

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Pham-Thi Nan, Dr

Role: primary

References

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Bousquet J, Gherasim A, de Blay F, Mathieu-Dupas E, Batot G, Laune D, Sousa-Pinto B, Zuberbier T, Pham-Thi N; MASK-cat study group. Proof-of-concept study of anti-Fel d 1 IgY antibodies in cat food using the MASK-air(R) app. Clin Transl Allergy. 2024 May;14(5):e12353. doi: 10.1002/clt2.12353.

Reference Type DERIVED
PMID: 38676659 (View on PubMed)

Other Identifiers

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KM00232

Identifier Type: -

Identifier Source: org_study_id

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