Effects of everyday allergen and skin, airway, and gut exposures on inflammation and barrier health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized crossover design, healthy adults will spend two inpatient stays of up to seven days each in a controlled environment with either common (typical Western) exposures or cleaner, 'pure' exposures, with a 4–6 week washout between stays. Participants are block-randomized within cohorts focused on skin, gastrointestinal, or airway outcomes and will use only provided foods and personal-care products while confined. Investigators will collect biospecimens and measure skin impedance, microbiome samples, and airway and GI parameters to detect short-term changes linked to exposure conditions. The protocol aims to connect real-world lifestyle and product exposures to measurable changes in inflammation and barrier function.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Hirsh D Komarow, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Jodi L Blake, R.N.
• Email: jodi.blake@nih.gov
• Phone: (301) 605-2896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.