Cat Allergy (Disorder)NCT07114133
A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies
A study testing Environmental Probiotic Spray Intervention in people with Cat Allergy (Disorder) and Allergic Rhinitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cat Allergy (Disorder), Allergic Rhinitis, Allergic Asthma
- What is being tested?
- Environmental Probiotic Spray Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
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:
Read more
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
- Being tested
- Environmental Probiotic Spray Intervention, Purified water spray (containing no active ingredients) as the placebo control
- Keywords
- Cat Allergy, Allergic Rhinitis, Allergic Asthma, Environmental Probiotics
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental Probiotic Spray InterventionOther
The probiotic strains include Bacillus subtilis YHX001J, Bacillus amyloliquefaciens YHX002J, and Bacillus velezensis YHX003J
Purified water spray (containing no active ingredients) as the placebo controlOther
Purified water spray
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Purified water spray (containing no active ingredients) as the placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the TNSS score at 3 Months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cat Allergy (Disorder)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114133
- Sponsor's protocol ID
- 2025-0723
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Efficacy of Environmental Probiotics in Patients With Cat Hair Allergies
- ClinicalTrials.gov ID
- NCT07114133
- Acronym / sponsor ID
- 2025-0723
- Conditions
- Cat Allergy (Disorder), Allergic Rhinitis, Allergic Asthma
- Keywords
- Cat Allergy, Allergic Rhinitis, Allergic Asthma, Environmental Probiotics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Environmental Probiotic Spray Intervention Arm | Experimental | Other: Environmental Probiotic Spray InterventionParticipants 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 |
| Purified Water Spray Intervention Arm | Placebo comparator | Other: Purified water spray (containing no active ingredients) as the placebo controlParticipants 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental Probiotic Spray InterventionThe probiotic strains include Bacillus subtilis YHX001J, Bacillus amyloliquefaciens YHX002J, and Bacillus velezensis YHX003J | Other | Environmental Probiotic Spray Intervention Arm |
| Purified water spray (containing no active ingredients) as the placebo controlPurified water spray | Other | Purified Water Spray Intervention Arm |
Primary outcome
Change from Baseline in the TNSS score at 3 Months
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Probiotic Spray Intervention in people with Cat Allergy (Disorder) and Allergic Rhinitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the TNSS score at 3 Months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.