Evaluation of the Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of the global Visual Analogic Scale (VAS) mean from Baseline period (Day 0- Day 15) at end period (Day 98-Day112)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change of the global Visual Analogic Scale (VAS) mean from Baseline period (Day 0- Day 15) at end period (Day 98-Day112)
时间窗: Baseline (Day 0- Day 15) and observation period (Day 98-Day112)
The approach will be considered beneficial if there is a statistically significant decrease in this criterion on the D98-J112 period compared to the baseline.
次要结局
未报告次要终点