HealthyEarly Phase 1NCT06637826
Study on the Relationship Between Indoor Environment, Use of Personal Disinfection Products, and Human Health
A Early Phase 1 study testing Quaternary Ammonium Compound Disinfectants and Alcohol-based Disinfectants in people with Healthy, run by National Natural Science Foundation of China at 1 site in China.
Trial summary
Research Purpose and Significance: Quaternary ammonium compounds (QACs), as cationic surfactants, are widely used in disinfectants, cosmetics, fabric softeners, hair conditioners, and other personal care products. They are a class of emerging organic pollutants commonly found in various environmental media. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quaternary Ammonium Compound Disinfectants and Alcohol-based Disinfectants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 31 Dec 2028
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students enrolled at Sun Yat-sen University Shenzhen Campus
- Willing to voluntarily participate, able to complete questionnaire surveys, exposure measurements, health scale assessments, and biological sample collection (including blood and urine)
Who cannot join
- Smoking
- Physically weak, unable to fully participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Research Purpose and Significance:
Quaternary ammonium compounds (QACs), as cationic surfactants, are widely used in disinfectants, cosmetics, fabric softeners, hair conditioners, and other personal care products. They are a class of emerging organic pollutants commonly found in various environmental media. Existing studies have shown that QACs exhibit immunotoxicity, reproductive toxicity, and developmental toxicity, which has led to increasing concern in developed countries such as Europe and the United States regarding their potential health risks. In 2015, the U.S. Food and Drug Administration (FDA) required manufacturers to provide more human safety data when adding QACs to personal care products. In 2016, the European Union banned the use of benzalkonium chloride in hand sanitizers and body washes. California, USA, announced that it will prohibit the use of Quaternium-15 in cosmetics and personal care products starting in 2025. Currently, China lacks health risk-based regulatory policies for QACs, highlighting a significant gap compared to developed countries. There is an urgent need to conduct detailed assessments of QAC pollution and human exposure to establish a foundation for evaluating the health risks associated with QACs.
Read more
In summary, investigating QAC pollution and human exposure in indoor environments is critical for understanding their health risks and will provide important theoretical support for establishing environmental health standards for QACs in China.
Research Methods:
- Participant Recruitment: This study will adopt a panel study design, recruiting 80 young student volunteers from an existing cohort.
- Study Design: Participants will be randomly assigned to two groups in a randomized crossover trial. Group A will use quaternary ammonium compound (QAC) disinfectant products (including laundry disinfectant, hand sanitizing wipes, and surface and floor disinfecting wipes), while Group B will use alcohol-based disinfectant products, both for a period of one month. After the first intervention, there will be a one-month washout period, followed by a crossover intervention where the groups switch products for another month. Participants will wear a custom environmental monitoring device according to the guidelines and will regularly complete health questionnaires, functional assessments, and biological sample collections.
- Exposure Measurement: External exposure to organic compounds in the environment will be monitored using silicone wristbands, while internal exposure will be assessed using blood and urine samples.
- Health Indicator Measurement: A combination of health scales and biochemical tests will be used to assess related health indicators. Health measurements will be conducted four times-once before and once after each intervention. Each session will include the following: a health questionnaire, 10 mL of fasting blood, 40 mL of morning urine, cognitive tests, EEG tests, near-infrared brain imaging, respiratory metabolic tests, arterial function tests, and body composition tests.
- Statistical Analysis:
Mixed-effects models and machine learning algorithms will be employed to assess the health effects of QAC and alcohol-based disinfectant products on the human body.
- Conditions
- Healthy
- Being tested
- Quaternary Ammonium Compound Disinfectants, Alcohol-based Disinfectants
- Keywords
- Quaternary Ammonium Disinfectants, Disinfectants, Indoor Environment, Human Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quaternary Ammonium Compound DisinfectantsBehavioural
Participants are instructed to use quaternary ammonium compound disinfectants during the 1st month (first intervention) and the 3rd month (second intervention) after enrollment, following the guidelines provided. The products include:
- Laundry disinfectant: Use at least twice per week.
- Hand sanitizing wipes: Use at least twice per day, individually packaged, recommended for use before meals.
- Surface disinfecting wipes: Use at least twice per day, individually packaged or multi-pack, recommended for use on surfaces in dormitories or classroom desks.
- Floor disinfecting wipes: Use at least twice per week, in multi-pack, recommended for use on the floor in personal activity areas in dormitories. These wipes can be used by hand or foot to wipe the floor.
After each use of the disinfectant products, participants are required to take a photo and send it to the research team as documentation.
Alcohol-based DisinfectantsBehavioural
Participants are instructed to use alcohol-based disinfectants during the 1st month (first intervention) and the 3rd month (second intervention) after enrollment, following the guidelines provided. The products include:
- Laundry disinfectant: Use at least twice per week.
- Hand sanitizing wipes: Use at least twice per day, individually packaged, recommended for use before meals.
- Surface disinfecting wipes: Use at least twice per day, individually packaged or multi-pack, recommended for use on surfaces in dormitories or classroom desks.
- Floor disinfecting wipes: Use at least twice per week, in multi-pack, recommended for use on the floor in personal activity areas in dormitories. These wipes can be used by hand or foot to wipe the floor.
After each use of the disinfectant products, participants are required to take a photo and send it to the research team as documentation.
| Study group | Role | What they receive |
|---|---|---|
| Blank Control Group | No intervention | Not described |
| Disinfectant Use Control Group | Experimental | Not described Receives: Behavioral: Quaternary Ammonium Compound Disinfectants; Behavioral: Alcohol-based Disinfectants |
What is being measured
The primary outcome is the main question the study is designed to answer.
64 Participants with Disinfectant Products-Related Adverse Events
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Natural Science Foundation of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiang Jianbang, National Natural Science Foundation of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637826
- Sponsor's protocol ID
- SYSU_SPHSZ_2024099
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Relationship Between Indoor Environment, Use of Personal Disinfection Products, and Human Health
- ClinicalTrials.gov ID
- NCT06637826
- Acronym / sponsor ID
- SYSU_SPHSZ_2024099
- Conditions
- Healthy
- Keywords
- Quaternary Ammonium Disinfectants, Disinfectants, Indoor Environment, Human Health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Natural Science Foundation of ChinaOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Oct 2024 (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.
Research Purpose and Significance:
Quaternary ammonium compounds (QACs), as cationic surfactants, are widely used in disinfectants, cosmetics, fabric softeners, hair conditioners, and other personal care products. They are a class of emerging organic pollutants commonly found in various environmental media. Existing studies have shown that QACs exhibit immunotoxicity, reproductive toxicity, and developmental toxicity, which has led to increasing concern in developed countries such as Europe and the United States regarding their potential health risks. In 2015, the U.S. Food and Drug Administration (FDA) required manufacturers to provide more human safety data when adding QACs to personal care products. In 2016, the European Union banned the use of benzalkonium chloride in hand sanitizers and body washes. California, USA, announced that it will prohibit the use of Quaternium-15 in cosmetics and personal care products starting in 2025. Currently, China lacks health risk-based regulatory policies for QACs, highlighting a significant gap compared to developed countries. There is an urgent need to conduct detailed assessments of QAC pollution and human exposure to establish a foundation for evaluating the health risks associated with QACs.
In summary, investigating QAC pollution and human exposure in indoor environments is critical for understanding their health risks and will provide important theoretical support for establishing environmental health standards for QACs in China.
Research Methods:
- Participant Recruitment: This study will adopt a panel study design, recruiting 80 young student volunteers from an existing cohort.
- Study Design: Participants will be randomly assigned to two groups in a randomized crossover trial. Group A will use quaternary ammonium compound (QAC) disinfectant products (including laundry disinfectant, hand sanitizing wipes, and surface and floor disinfecting wipes), while Group B will use alcohol-based disinfectant products, both for a period of one month. After the first intervention, there will be a one-month washout period, followed by a crossover intervention where the groups switch products for another month. Participants will wear a custom environmental monitoring device according to the guidelines and will regularly complete health questionnaires, functional assessments, and biological sample collections.
- Exposure Measurement: External exposure to organic compounds in the environment will be monitored using silicone wristbands, while internal exposure will be assessed using blood and urine samples.
- Health Indicator Measurement: A combination of health scales and biochemical tests will be used to assess related health indicators. Health measurements will be conducted four times-once before and once after each intervention. Each session will include the following: a health questionnaire, 10 mL of fasting blood, 40 mL of morning urine, cognitive tests, EEG tests, near-infrared brain imaging, respiratory metabolic tests, arterial function tests, and body composition tests.
- Statistical Analysis:
Mixed-effects models and machine learning algorithms will be employed to assess the health effects of QAC and alcohol-based disinfectant products on the human body.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blank Control Group | No intervention | – |
| Disinfectant Use Control Group | Experimental | Behavioral: Quaternary Ammonium Compound Disinfectants, Behavioral: Alcohol-based Disinfectants |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Students enrolled at Sun Yat-sen University Shenzhen Campus
- Willing to voluntarily participate, able to complete questionnaire surveys, exposure measurements, health scale assessments, and biological sample collection (including blood and urine)
Key exclusion criteria (2 listed)
- Smoking
- Physically weak, unable to fully participate 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 |
|---|---|---|
| Quaternary Ammonium Compound DisinfectantsParticipants are instructed to use quaternary ammonium compound disinfectants during the 1st month (first intervention) and the 3rd month (second intervention) after enrollment, following the guidelines provided. The products include: * Laundry disinfectant: Use at least twice per week. * Hand sanitizing wipes: Use at least twice per day, individually packaged, recommended for use before meals. * Surface disinfecting wipes: Use at least twice per day, individually packaged or multi-pack, recommended for use on surfaces in dormitories or classroom desks. * Floor disinfecting wipes: Use at least twice per week, in multi-pack, recommended for use on the floor in personal activity areas in dormitories. These wipes can be used by hand or foot to wipe the floor. After each use of the disinfectant products, participants are required to take a photo and send it to the research team as documentation. | Behavioural | Disinfectant Use Control Group |
| Alcohol-based DisinfectantsParticipants are instructed to use alcohol-based disinfectants during the 1st month (first intervention) and the 3rd month (second intervention) after enrollment, following the guidelines provided. The products include: * Laundry disinfectant: Use at least twice per week. * Hand sanitizing wipes: Use at least twice per day, individually packaged, recommended for use before meals. * Surface disinfecting wipes: Use at least twice per day, individually packaged or multi-pack, recommended for use on surfaces in dormitories or classroom desks. * Floor disinfecting wipes: Use at least twice per week, in multi-pack, recommended for use on the floor in personal activity areas in dormitories. These wipes can be used by hand or foot to wipe the floor. After each use of the disinfectant products, participants are required to take a photo and send it to the research team as documentation. | Behavioural | Disinfectant Use Control Group |
Primary outcome
64 Participants with Disinfectant Products-Related Adverse Events
Time frame: From enrollment to the end of treatment at 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 12 Aug 2026.
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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. This study is not recruiting at the moment.
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 Early Phase 1 study testing Quaternary Ammonium Compound Disinfectants and Alcohol-based Disinfectants in people with Healthy, run by National Natural Science Foundation of China 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 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
64 Participants with Disinfectant Products-Related Adverse Events (time frame: From enrollment to the end of treatment at 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 12 Aug 2026.