NCT06637826 Study on the Relationship Between Indoor Environment, Use of Personal Disinfection Products, and Human Health
| NCT ID | NCT06637826 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | National Natural Science Foundation of China |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 64 participants in total. It began in 2024-10-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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: 1. Participant Recruitment: This study will adopt a panel study design, recruiting 80 young student volunteers from an existing cohort. 2. 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. 3. 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. 4. 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. 5. 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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Smoking * Physically weak, unable to fully participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06637826 clinical trial?
This trial is open to participants of all sexes, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06637826 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06637826 currently recruiting?
Yes, NCT06637826 is actively recruiting participants. Contact the research team at xiangjb@mail.sysu.edu.cn for enrollment information.
Where is the NCT06637826 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT06637826 clinical trial?
NCT06637826 is sponsored by National Natural Science Foundation of China. The trial plans to enroll 64 participants.