Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07271381

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-26

120

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how everyday exposure to common environmental chemicals and lifestyle factors may affect health, especially related to allergic and inflammatory conditions. The study aims to explore links between these exposures and changes in skin, gut, and airway health in healthy adults aged 18 to 80 years. This research is designed to better understand how pollution, processed foods, and personal care products might influence inflammation and related illnesses. Participants will have two separate 7-day inpatient stays in a controlled hospital setting spaced 4 to 6 weeks apart. During one stay, they will be exposed to a pure environment with filtered air, unprocessed foods, and low-chemical personal care products. In the other stay, they will be exposed to common environmental chemicals targeting skin, gastrointestinal, or airway health, or all three combined. The study uses a crossover design where participants experience both conditions in random order. Throughout the study, participants will provide various samples including blood, skin cells, urine, mouth swabs, and stool. They will undergo lung, smell, and skin health tests. These assessments will also be repeated during outpatient visits two weeks after each inpatient stay. Researchers will measure changes in skin impedance, gut microbiome diversity, airway resistance, inflammatory markers, and quality of life. The study includes detailed monitoring of physical activity and symptoms to understand the impact of different exposures on health over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent.
  • Age 18 to 80 years.
  • Agreement to follow lifestyle considerations during the study.
  • Ability to stick to assigned diets during inpatient stays.
  • Ability to speak English.
  • Willingness to allow storage of samples and data for future research.
Not Eligible

You will not qualify if you...

  • Diagnosis of atopic asthma, atopic dermatitis, food allergy, chronic hives, autoimmune, metabolic, chronic infectious or inflammatory diseases.
  • Positive Phadiatop allergy test.
  • History of cancer within the past 5 years.
  • Use of medications affecting skin, gut, or airway symptoms, including recent antibiotics or corticosteroids.
  • Current chemotherapy treatment.
  • Infection with HIV, hepatitis B, or hepatitis C.
  • Receipt of any vaccine within 1 month before enrollment.
  • Use of oral antibiotics within 3 to 6 months before enrollment.
  • Use of corticosteroids within 1 month before enrollment.
  • Participation in another treatment or intervention study within 3 months before enrollment.
  • Currently pregnant or breastfeeding.
  • Current smoking or vaping.
  • Any other condition deemed risky by investigators or affecting study results.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Exposure Period

Duration - Up to 15 days including washout

Participants spend up to 7 days as an inpatient in a controlled environment with assigned exposures to either common environmental toxins or cleaner, control exposures. They then have a brief washout period followed by a crossover to the other exposure for another up to 7 days inpatient stay. Various biospecimens and data are collected throughout the inpatient stays to identify changes in skin, gastrointestinal, and airway parameters.

2 inpatient stays of up to 7 days each with a brief washout period in between

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

J

Jodi L Blake, R.N.

H

Hirsh D Komarow, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

6

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Published Research Related To This Trial

Exposure to isocyanates predicts atopic dermatitis prevalence and disrupts therapeutic pathways in commensal bacteria.

Jordan Zeldin, Prem Prashant Chaudhary, Jacquelyn Spathies...

https://pubmed.ncbi.nlm.nih.gov/36608129

The epithelial barrier: The gateway to allergic, autoimmune, and metabolic diseases and chronic neuropsychiatric conditions.

Duygu Yazici, Ismail Ogulur, Yagiz Pat...

https://pubmed.ncbi.nlm.nih.gov/37801907