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Enrolling by invitationNCT07114133Updated Aug 11, 2025

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

An interventional study of Environmental Probiotic Spray Intervention and Purified water spray (containing no active ingredients) as the placebo control in Cat Allergy (Disorder), Allergic Rhinitis and Allergic Asthma, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cat Allergy (Disorder)
  • Allergic Rhinitis
  • Allergic Asthma

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Keywords

  • Cat Allergy
  • Allergic Rhinitis
  • Allergic Asthma
  • Environmental Probiotics
03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 100 is above the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Browse Second Affiliated Hospital, School of Medicine, Zhejiang University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    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

    Other: Environmental Probiotic Spray Intervention

  • Placebo comparator
    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

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

Interventions

  • OtherEnvironmental Probiotic Spray Intervention

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

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

    Purified water spray

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the TNSS score at 3 Months

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 12 months after the start.

Of 66 non-industry interventional studies with no phase under Rhinitis, Allergic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 12 months is close to that.

Counting every sponsor, half of 87 studies reached it within 11 months; a quarter within 4 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2025
First posted
Aug 11, 2025
StartActual
Jun 30, 2025
Primary completionEst.
Jun 30, 2026
CompletionEst.
Jun 30, 2027
Last update
Aug 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07114133
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Jun 30, 2025
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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