A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Environmental Probiotic Spray Intervention, Purified water spray (containing no active ingredients) as the placebo control.
- Who it may be relevant to
- Registry conditions: Cat Allergy (Disorder), Allergic Rhinitis, Allergic Asthma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other Environmental Probiotic Spray Intervention
The probiotic strains include Bacillus subtilis YHX001J, Bacillus amyloliquefaciens YHX002J, and Bacillus velezensis YHX003J - Other Purified water spray (containing no active ingredients) as the placebo control
Purified water spray
Primary outcome measures
- Change from Baseline in the TNSS score at 3 Months [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07114133 · 2025-0723