A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from Baseline in the TNSS score at 3 Months
研究概览
简要总结
Objective of this clinical trial:
The goal of this clinical study is to evaluate whether an environmental probiotic spray can improve symptoms in adults with cat allergy-induced allergic rhinitis (AR) and allergic asthma (AA). It will also assess the safety of the probiotic spray. The main questions it aims to answer are:
Does the environmental probiotic spray reduce the severity of nasal and asthma symptoms in participants? Are there any adverse effects observed in participants using the probiotic spray? Researchers will compare the environmental probiotic spray group to a placebo group (a look-alike spray containing no active ingredients) to determine if the probiotic spray is effective in managing allergic rhinitis and asthma symptoms.
Participants will:
Receive the environmental probiotic spray or placebo daily for 3 months Attend monthly clinic visits for checkups and assessments Undergo a final evaluation at 3 months, including symptom scoring and safety checks
Key Assessments:
Total Nasal Symptom Score (TNSS) for allergic rhinitis Asthma Control Test (ACT) score for allergic asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18-70 years；
- •Diagnosed with cat allergy (cat dander-specific IgE level ≥ class 2: > 0.7 IU/mL) and allergic rhinitis with or without allergic asthma;
- •Residing in the same living environment for at least 3 months (and no plans to change residence within the next 6 months);
- •Patients receiving conventional symptomatic treatment.
排除标准
- •Presence of other severe systemic diseases;
- •Residence duration < 3 months or plans to change residence within the next 6 months;
- •Pregnancy;
- •Current or planned use of biologic therapy;
- •Any other condition that, in the investigator's judgment, may pose significant risks to the participant if enrolled in the study.
研究组 & 干预措施
Environmental Probiotic Spray Intervention Arm
Participants in this arm will administer the environmental probiotic spray at home according to the following protocol:
First bottle: 3 times daily (TID), 30 actuations per administration Subsequent bottles (from second bottle onward): Once daily (QD), 15 actuations per administration Total duration: 3 months
干预措施: Environmental Probiotic Spray Intervention (Other)
Purified Water Spray Intervention Arm
Participants in this arm will administer the purified water spray at home according to the following protocol:
First bottle: 3 times daily (TID), 30 actuations per administration Subsequent bottles (from second bottle onward): Once daily (QD), 15 actuations per administration Total duration: 3 months
干预措施: Purified water spray (containing no active ingredients) as the placebo control (Other)
结局指标
主要结局
Change from Baseline in the TNSS score at 3 Months
时间窗: 3 months
次要结局
未报告次要终点