THREAT Study: Understanding Everyday Exposures and Your Health
This study, called THREAT, aims to understand how common substances we encounter daily might affect allergic and inflammatory conditions. Researchers will compare the effects of everyday products like toothpaste, skin lotion, and processed foods (containing ingredients like sodium lauryl sulfate or SLS) with "cleaner" alternatives that are SLS-free, toxin-free, and minimally processed. You could be eligible if you are a healthy person between 18 and 80 years old and can speak English. The study will look for changes in your skin, gut (gastrointestinal), and airways. The current status of this study is unclear, and it plans to enroll 120 participants.
- Study design
- This interventional study involves two stages with a crossover design, meaning participants will experience both types of environments. It plans to enroll 120 participants.
- What's involved
- You would have two separate 7-day stays in the hospital, spaced 4 to 6 weeks apart. During these stays, you would adhere to specific diets and product exposures, and allow collection of samples and data.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured at Baseline and at the completion of each inpatient stay.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins
At a glance
Conditions
NCT07271381
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
National Institutes of Health Clinical Center
Bethesda, Marylandstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Hirsh D Komarow, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Cohort 1 (skin): The primary endpoint for the skin substudy is the skin impedance change response from the common environment.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.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.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.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.