NCT07271381 THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins
| NCT ID | NCT07271381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Condition | Allergic |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2030-12-30 |
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.
This trial targets 120 participants in total. It began in 2026-04-15 with a primary completion date of 2030-12-30.
⚠ 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
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....
Eligibility Criteria
* INCLUSION CRITERIA: To participate in this study, an individual must meet all of the following criteria: 1. Ability to provide informed consent. 2. Age 18-80 years. 3. Agreement to adhere to lifestyle considerations. 4. Ability to exclusively adhere to UPD and MPD during inpatient stay. 5. Ability to speak English. 6. 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: 1. Diagnosis of atopic (physician-diagnosed asthma, AD, food allergy, chronic hives), autoimmune, metabolic, or chronic infectious or inflammatory diseases. 2. Current or history of neoplastic disease within 5 years. 3. 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). 4. Current receipt of chemotherapy. 5. HIV, hepatitis B, or hepatitis C infection. 6. Receipt of any vaccine within 1 month prior to enrollment. 7. Receipt of oral antibiotics within 3-6 months prior to enrollment. 8. Use of topical, oral, or parental corticosteroids within 1 month prior to enrollment. 9. Participation in another treatment or intervention study within 3 months prior to enrollment. 10. Currently pregnant or lactating. 11. Currently smoking or vaping. 12. Any other condition or intercurrent illness deemed by the investigators to be of potential risk to the participant or validity of study results.
Contact & Investigator
Hirsh D Komarow, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Frequently Asked Questions
Who can join the NCT07271381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Allergic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07271381 currently recruiting?
Yes, NCT07271381 is actively recruiting participants. Contact the research team at jodi.blake@nih.gov for enrollment information.
Where is the NCT07271381 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT07271381 clinical trial?
NCT07271381 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID). The principal investigator is Hirsh D Komarow, M.D. at National Institute of Allergy and Infectious Diseases (NIAID). The trial plans to enroll 120 participants.