Recruiting

Environmental Exposure

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT07271381

Conditions

Allergic

Inflammatory

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Environmental Exposures

Control Exposures

Study Details

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....

Conditions

Allergic

Inflammatory

Study ID

NCT07271381

Start date

Apr 15, 2026

Status verified date

Aug 3, 2026

Completion date

Jan 30, 2031

Anticipated

Primary completion date

Dec 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

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.

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 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 ]
  • 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 (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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jodi L Blake, R.N.

(301) 605-2896jodi.blake@nih.gov

Hirsh D Komarow, M.D.

(301) 594-2197komarowh@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Jodi Blake

301-605-2896jodi.blake@nih.gov

Komarow Hirsh

(301) 594-2197komarowh@mail.nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Aug 10, 2026

Last verified

Aug 3, 2026

Keywords

  • Environmental Exposures
  • Skin barrier dysfunction
  • Skin impedance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-08-10.