THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07271381
Status
Recruiting
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Conditions

  • Allergic
  • Inflammatory

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Environmental Exposures — OTHER
    Toothpaste, skin lotion, hand soap, body wash, laundry detergent, shampoo containing sodium lauryl sulfate (SLS), wall art with foam and polyurethane, and processed food.
  • Control Exposures — OTHER
    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.

Study Details

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....

Key Dates

Start date
Apr 15, 2026
Status verified
May 2026
Primary completion
Dec 30, 2030
Completion
Jan 30, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Common Airway
    Exposure to a sham air purifier, and wall art with foam and polyurethane.
  • Experimental: Common Gastrointestinal
    Exposure to an ultra processed diet.
  • Experimental: Common Skin
    Exposure to toothpaste, body wash, shampoo, and detergents containing sodium lauryl sulfate and other hazardous agents (commonly used likely toxic ingredients).
  • Other: Pure Airway
    Exposure to wall art without foam and polyurethane.
  • Other: Pure Gastrointestinal
    Exposure to a a minimally processed diet.
  • Other: Pure Skin
    Exposure to SLS-free and toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Jodi Blake
[email protected]
301-605-2896
Komarow Hirsh
[email protected]
(301) 594-2197

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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