Allergic RhinitisNCT07110311
Impact of Pet Cats on Nasal and Gut Microbiota in Patients With Cat Allergen Allergy
An observational study of Allergic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
It has been reported that the incidence of allergic rhinitis (AR) is as high as 24.1% in adults and 16.8% in children in China. A study explored the changes in the incidence of AR in China, and the study showed that the incidence of AR in many cities in China increased significantly from 2005 to 2011. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to 1 Nov 2032
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with cat-allergic rhinitis in the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University.
Who may be able to join
- Adult patients (18-65 years).
- Patients with moderate to severe dust mite allergic rhinitis were diagnosed based on clinical history and positive cat allergen sensitization tests (skin prick test and/or specific IgE).
- Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University.
Who cannot join
- Patients who refused to accept specimen and questionnaire collection.
- Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210000
Nanjing, Jiangsu
Lei Cheng, PhD, +8613776620807, chenglei@jsph.org.cn
About this study
Official title: Effects of Pet Cats on Nasal and Intestinal Microorganisms in Patients With Allergic Rhinitis Who Are Allergic to Cat Allergen
It has been reported that the incidence of allergic rhinitis (AR) is as high as 24.1% in adults and 16.8% in children in China. A study explored the changes in the incidence of AR in China, and the study showed that the incidence of AR in many cities in China increased significantly from 2005 to 2011. The latest Chinese guidelines for the diagnosis and treatment of allergic rhinitis pointed out that AR is an independent risk factor for asthma, and 40% of AR patients can be complicated with asthma. CARRAD reported that in adult asthma patients who received skin prick test or serum specific IgE (sIgE) for allergens, The positive rates of at least one allergen were 65.4% and 75.4%, respectively. With the acceleration of urbanization and the improvement of people's economic level, more and more families keep pets. Pets can promote people's physical and mental health, but there are also more and more people who are allergic to pets. Some studies have shown that pets are the third major allergen of respiratory allergic diseases, next to dust mites and pollen. Cats are by far one of the most popular pets, but in recent years, the prevalence of cat allergen has gradually increased. Animal allergens are present in saliva, urine, and dander, and they spread into the environment by adhering to the hair and dander of the animals, such that even in homes without pets, the level of allergens in the environment is sufficient to sensitize people. However, at present, the microbial impact of the microorganisms carried by pet cats on their owners and the living environment is unknown.
- Conditions
- Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AR patients with cat ownership. | Not described | |
| AR patients without cat ownership. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metagenomic Sequencing
Metagenomic sequencing was performed on the collected patient samples, cat fecal samples, and environmental samples to obtain relevant information about the microbiota
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start14 Nov 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Cheng, PhD, Study chair, The First Affiliated Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110311
- Sponsor's protocol ID
- 2023-SR-797
- Status last verified
- Nov 2024
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- 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 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pet Cats on Nasal and Intestinal Microorganisms in Patients With Allergic Rhinitis Who Are Allergic to Cat Allergen
- ClinicalTrials.gov ID
- NCT07110311
- Acronym / sponsor ID
- 2023-SR-797
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 7 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.
It has been reported that the incidence of allergic rhinitis (AR) is as high as 24.1% in adults and 16.8% in children in China. A study explored the changes in the incidence of AR in China, and the study showed that the incidence of AR in many cities in China increased significantly from 2005 to 2011. The latest Chinese guidelines for the diagnosis and treatment of allergic rhinitis pointed out that AR is an independent risk factor for asthma, and 40% of AR patients can be complicated with asthma. CARRAD reported that in adult asthma patients who received skin prick test or serum specific IgE (sIgE) for allergens, The positive rates of at least one allergen were 65.4% and 75.4%, respectively. With the acceleration of urbanization and the improvement of people's economic level, more and more families keep pets. Pets can promote people's physical and mental health, but there are also more and more people who are allergic to pets. Some studies have shown that pets are the third major allergen of respiratory allergic diseases, next to dust mites and pollen. Cats are by far one of the most popular pets, but in recent years, the prevalence of cat allergen has gradually increased. Animal allergens are present in saliva, urine, and dander, and they spread into the environment by adhering to the hair and dander of the animals, such that even in homes without pets, the level of allergens in the environment is sufficient to sensitize people. However, at present, the microbial impact of the microorganisms carried by pet cats on their owners and the living environment is unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR patients with cat ownership. | – | – |
| AR patients without cat ownership. | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with cat-allergic rhinitis in the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University.
Key inclusion criteria (3 listed)
- Adult patients (18-65 years).
- Patients with moderate to severe dust mite allergic rhinitis were diagnosed based on clinical history and positive cat allergen sensitization tests (skin prick test and/or specific IgE).
- Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University.
Key exclusion criteria (2 listed)
- Patients who refused to accept specimen and questionnaire collection.
- Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metagenomic Sequencing
Time frame: 3 years
Metagenomic sequencing was performed on the collected patient samples, cat fecal samples, and environmental samples to obtain relevant information about the microbiota
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 7 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.
Lei Cheng, PhD study chair
The First Affiliated Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by The First Affiliated Hospital with Nanjing Medical University 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 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. 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?
Contact Lei Cheng, PhD (+8613776620807, chenglei@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metagenomic Sequencing (time frame: 3 years). 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 7 Aug 2025.