NCT07271381 · National Institute of Allergy and Infectious Diseases (NIAID)
THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins
What this study is about
Background: Allergic and inflammatory conditions have been increasing over the years. Many factors may play a role in this. Every day, people are exposed to pollution and chemicals in our foods, clothing, and all of the cleaning, hygiene, and other products we use. Studies have suggested there may be links between these environmental exposures and allergic and inflammatory illnesses.
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Background: Allergic and inflammatory conditions have been increasing over the years. Many factors may play a role in this. Every day, people are exposed to pollution and chemicals in our foods, clothing, and all of the cleaning, hygiene, and other products we use. Studies have suggested there may be links between these environmental exposures and allergic and inflammatory illnesses. Researchers want to know more about how these exposures affect our health. Objective: To learn how everyday exposure to common substances affects people's health. Eligibility: Healthy people aged 18 to 80 years. Design: Participants will have 2 stays in the hospital. Each stay will last 7 days, and the stays will be spaced 4 to 6 weeks apart. During both stays, participants will remain confined to their room. They will eat only food from the menu, and they will use only provided products for personal care. (They may bring their own electronic devices, such as their phone and computer.) One stay will be in a pure room. Participants will breathe filtered air, eat unprocessed foods, and use personal care products with fewer chemicals. One stay will be in a room that allows exposure to common environmental chemicals. Some participants will be limited to only 1 type of exposure: chemicals thought to affect only skin, gut, or respiratory health. Some participants will be exposed to all 3 types. Participants will undergo testing. Blood, skin cell, urine, mouth swabs, and stool samples will be taken. They will have lung tests, smell tests, and tests that measure the health of their skin. These tests will be repeated in outpatient visits 2 weeks after each hospital stay....
Interventions
OTHER
Environmental Exposures
Toothpaste, skin lotion, hand soap, body wash, laundry detergent, shampoo containing sodium lauryl sulfate (SLS), wall art with foam and polyurethane, and processed food.
OTHER
Control Exposures
SLS-free, toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets, a minimally processed diet, and wall art without foam and polyurethane.
Primary outcome measures
Cohort 1 (skin): The primary endpoint for the skin substudy is the skin impedance change response from the common environment.
Time frame: Baseline and completion of inpatient stay
Cohort 1: Determine the effects of common vs. pure exposures on the skin in healthy volunteers.
Cohort 2 (GI): The primary endpoint for the GI substudy is analogous to that of the skin substudy, except replacing skin impedance with the Shannon-Weaver diversity index measured on the gut microbiome that measures metabolic diversity.
Time frame: Baseline and completion of inpatient stay
Cohort 2: Determine the effects of common vs. pure exposures on GI tract in healthy volunteers.
Cohort 2 (Airway): The primary endpoint for the airway substudy is the airway maximum change response from the common environment minus the airway maximum change response from the pure environment.
Time frame: Baseline and completion of inpatient stay
Cohort 3: Determine the effects of common vs. pure exposures on airway in healthy volunteers
Based on combined exposures from all 3 organ systems and randomization design, repeat primary and secondary endpoint responses of Stage 1.
Time frame: Baseline and completion of inpatient stay
Stage 2 Primary Objective: Determine the combined effects of skin, GI, and airway exposures of the respective organ systems in healthy volunteers.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To participate in this study, an individual must meet all of the following criteria:
- Ability to provide informed consent.
- Age 18-80 years.
- Agreement to adhere to lifestyle considerations.
- Ability to exclusively adhere to UPD and MPD during inpatient stay.
- Ability to speak English.
- Willing to allow storage of samples and data for future research.
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of atopic (physician-diagnosed asthma, AD, food allergy, chronic hives), autoimmune, metabolic, or chronic infectious or inflammatory diseases.
- Current or history of neoplastic disease within 5 years.
- Use of medication(s) that may affect skin, GI, and/or airway symptoms and may have an effect on skin microbiome, GI microbiome (topical or oral antibiotic use may require 3-6 month delay in enrollment for gut microbiome repopulation, see #8), and/or serum cytokines (other than oral birth control, which is not exclusionary and is allowed during participation provided there is consistence use for 3-6 months prior to enrollment).
- Current receipt of chemotherapy.
- HIV, hepatitis B, or hepatitis C infection.
- Receipt of any vaccine within 1 month prior to enrollment.
- Receipt of oral antibiotics within 3-6 months prior to enrollment.
- Use of topical, oral, or parental corticosteroids within 1 month prior to enrollment.
- Participation in another treatment or intervention study within 3 months prior to enrollment.
- Currently pregnant or lactating.
- Currently smoking or vaping.
- Any other condition or intercurrent illness deemed by the investigators to be of potential risk to the participant or validity of study results.
Where
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations