A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies

NCT ID: NCT07114133

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-06-30

Brief Summary

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

Conditions

Cat Allergy (Disorder); Allergic Rhinitis; Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Environmental Probiotic Spray Intervention

Intervention Type: OTHER

The probiotic strains include Bacillus subtilis YHX001J, Bacillus amyloliquefaciens YHX002J, and Bacillus velezensis YHX003J

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

Group Type: PLACEBO_COMPARATOR

Purified water spray (containing no active ingredients) as the placebo control

Intervention Type: OTHER

Purified water spray

Interventions

Environmental Probiotic Spray Intervention

The probiotic strains include Bacillus subtilis YHX001J, Bacillus amyloliquefaciens YHX002J, and Bacillus velezensis YHX003J

Intervention Type: OTHER

Purified water spray (containing no active ingredients) as the placebo control

Purified water spray

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2025-0723

Identifier Type: -

Identifier Source: org_study_id