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

NCT07114133 | Enrolling By Invitation

• 1 other identifier: 2025-0723
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Cat Allergy; Allergic Rhinitis; Allergic Asthma; Environmental Probiotics

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the TNSS score at 3 Months

  3 months

Study Arms (2)

Environmental Probiotic Spray Intervention Arm

EXPERIMENTAL

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

Other: Environmental Probiotic Spray Intervention

Purified Water Spray Intervention Arm

PLACEBO COMPARATOR

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

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

Interventions

Environmental Probiotic Spray Intervention OTHER

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

Environmental Probiotic Spray Intervention Arm

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

Purified water spray

Purified Water Spray Intervention Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 11, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)