AllergicNCT07271381
THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins
A study testing Environmental Exposures in people with Allergic and Inflammatory, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Allergic, Inflammatory
- What is being tested?
- Environmental Exposures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 30 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in this study, an individual must meet all of the following criteria:
- Ability to provide informed consent.
- Age 18-80 years.
- Agreement to adhere to lifestyle considerations.
- Ability to exclusively adhere to UPD and MPD during inpatient stay.
- Ability to speak English.
- Willing to allow storage of samples and data for future research.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of atopic (physician-diagnosed asthma, AD, food allergy, chronic hives), autoimmune, metabolic, or chronic infectious or inflammatory diseases.
- Current or history of neoplastic disease within 5 years.
- 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).
- Current receipt of chemotherapy.
- HIV, hepatitis B, or hepatitis C infection.
Show all 13Show fewer
- Receipt of any vaccine within 1 month prior to enrollment.
- Receipt of oral antibiotics within 3-6 months prior to enrollment.
- Use of topical, oral, or parental corticosteroids within 1 month prior to enrollment.
- Participation in another treatment or intervention study within 3 months prior to enrollment.
- Currently pregnant or lactating.
- Currently smoking or vaping.
- Any other condition or intercurrent illness deemed by the investigators to be of potential risk to the participant or validity of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Jodi Blake, 301-605-2896, jodi.blake@nih.gov
Komarow Hirsh, (301) 594-2197, komarowh@mail.nih.gov
About this study
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.
Read more
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....
Read the detailed description
Study Description:
In this study, we aim to investigate whether there is a link between lifestyle exposures, inflammation, and disease by exposing participants to environments with real-world levels of common skin and hair products (eg, soaps, shampoos), a typical Western diet of processed food, and/or ubiquitous air exposures, and to environments with cleaner, more natural contactants and less processed food. Participants will spend up to 7 days as an inpatient in a controlled environment with the assigned exposures, and up to 7 days as an inpatient in a cleaner environment. We will collect a variety of biospecimens and data throughout the inpatient stays to identify changes in skin, gastrointestinal (GI), and airway survey parameters.
The study will consist of 2 stages with a crossover design in each stage. Stage 1 will be divided into 3 cohorts: one cohort to identify changes in skin, one for GI changes, and one for airway changes. Within each cohort, participants will be block randomized to spend up to 7 days in the inpatient unit with either the specifically assigned experimental (common) or control (pure) exposures. Within each of the 3 cohorts, the common exposures will target a specific organ system (skin, GI, or airway). After a brief washout period, participants will then crossover to the other targeted exposure (ie, from common to pure or vice versa), for an additional inpatient stay of up to 7 days. The findings from each participant s first inpatient stay will be compared to findings from their crossover second inpatient stay.
The data collected from Stage 1 may be used to clarify the survey parameters of participants enrolled into Stage 2, in which new participants will be randomized to all common exposure domains (skin + GI + airway) vs. pure (control) and then a crossover.
Objectives:
Stage 1 Primary Objectives:
- Cohort 1: Determine the effects of common vs. pure exposures on the skin in healthy volunteers.
- Cohort 2: Determine the effects of common vs. pure exposures on the GI tract in healthy volunteers.
- Cohort 3: Determine the effects of common vs. pure exposures on the airway in healthy volunteers.
Stage 1 Secondary Objective: Determine the combined effects of common vs. pure exposures on the skin, gut, and airway in healthy volunteers.
Stage 2 Primary Objective: Determine the combined effects of common vs. pure exposures on the skin, gut, and airway in healthy volunteers.
Endpoints:
Stage 1 Primary Endpoints:
- Cohort 1 (skin): The primary endpoint for the skin substudy is the skin impedance change response from the common environment (as a log geometric mean ratio [GMR]) minus the mean skin impedance change response from the pure environment (as a log GMR). For each crossover intervention period (common or pure), we measure the GMR as the ratio of the geometric mean (GM) of the average skin impedance measurements at the last day of the inpatient stay over the GM of the average skin impedance measurements at day 0 (baseline).
- 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 (a measure of metabolic diversity) measured on the gut microbiome.
- Cohort 3 (airway): The primary endpoint for the airway substudy is the airway maximum change response from the common environment (as the log of the GM of the maximum of the daily change response) minus the airway maximum change response from the pure environment. For each crossover intervention period (common or pure), we measure each individual s daily change response as airway resistance (R5) measured at each day of the inpatient stay over the R5 at day 0 (baseline).
Stage 1 Secondary Endpoints will compare common vs pure crossover period responses as follows:
- Cohort 1 (skin):
- Proportion of participants that experience a 30% reduction in skin impedance from admission to any time point during inpatient stay.
- Change in metabolic functional analysis and/or specific taxa of skin microbiome from admission to last day of the inpatient stay.
- Change in skin metabolomics by tape strip analysis during study exposure.
- Cohort 2 (GI):
- Change in metabolic functional analysis and/or specific taxa of gut microbiome.
- Change in diversity index, metabolic functional analysis, and/or specific taxa of oral microbiome.
- Cohort 3 (airway):
- Increase in R5 from admission to last day of inpatient stay by impulse oscillometry (IOS).
- All 3 Cohorts:
- Change in serum and/or intradermal fluid inflammatory markers during study exposure.
- Change in serum lipopolysaccharides (LPS) and bacterial translocation markers (a marker of GI barrier integrity) during study exposure.
- Change in quality of life from baseline during exposures to contactants.
- Changes in activity from baseline during study exposure.
- Change in sense of smell/taste during study exposure.
- Correlation of exposures with activity and/or symptoms.
Stage 2 Endpoint: Based on isolated exposures from single organ systems and randomization design in Stage 1, repeat primary and secondary endpoint responses of Stage 1.
- Conditions
- Allergic, Inflammatory
- Being tested
- Environmental Exposures, Control Exposures
- Keywords
- Environmental Exposures, Skin barrier dysfunction, Skin impedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental ExposuresOther
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 ExposuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Common Airway | Experimental | Exposure to a sham air purifier, and wall art with foam and polyurethane. Receives: Other: Environmental Exposures |
| Common Gastrointestinal | Experimental | Exposure to an ultra processed diet. Receives: Other: Environmental Exposures |
| Common Skin | Experimental | Exposure to toothpaste, body wash, shampoo, and detergents containing sodium lauryl sulfate and other hazardous agents (commonly used likely toxic ingredients). Receives: Other: Environmental Exposures |
| Pure Airway | Other | Exposure to wall art without foam and polyurethane. Receives: Other: Control Exposures |
| Pure Gastrointestinal | Other | Exposure to a a minimally processed diet. Receives: Other: Control Exposures |
| Pure Skin | Other | Exposure to SLS-free and toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets. Receives: Other: Control Exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1 (skin): The primary endpoint for the skin substudy is the skin impedance change response from the common environment.
Cohort 1: Determine the effects of common vs. pure exposures on the skin in healthy volunteers.
Measured: 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.
Cohort 2: Determine the effects of common vs. pure exposures on GI tract in healthy volunteers.
Measured: 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.
Cohort 3: Determine the effects of common vs. pure exposures on airway in healthy volunteers
Measured: 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.
Stage 2 Primary Objective: Determine the combined effects of skin, GI, and airway exposures of the respective organ systems in healthy volunteers.
Measured: Baseline and completion of inpatient stay
Secondary outcomes (9)
Change metabolic functional analysis, and/or specific taxa of skin microbiome.
Compare common vs. pure crossover period responses.
Measured: Baseline and completion of inpatient stay.
Change in skin metabolomics by tape strip analysis during study exposure.
Compare common vs. pure crossover period responses.
Measured: Baseline and completion of inpatient stay.
Change in metabolic functional analysis, and/or specific taxa of gut microbiome.
Compare common vs. pure crossover period responses.
Measured: Baseline and completion of inpatient stay.
Change in diversity index, metabolic functional analysis, and/or specific taxa of oral microbiome. Perform pair-wise and p-crest analysis.
Compare common vs. pure crossover period responses.
Measured: Baseline and completion of inpatient stay.
Increase in airway resistance (using R5 or R5-R20) from admission to last day (or the maximum of the daily measurements) of inpatient stay by impulse oscillometry (IOS).
Compare common vs. pure crossover period responses.
Measured: Baseline and completion of inpatient stay.
Change in FEV1, FVC using spirometry.
Compare common vs. pure crossover period responses.
Measured: Baseline and last day of inpatient stay.
Change in serum and/or intradermal fluid inflammatory markers.
Compare common vs. pure crossover period responses.
Measured: Baseline and last day of inpatient stay.
Change in serum lipopolysaccharides (LPS) and bacterial translocation markers (a marker of GI barrier integrity).
Compare common vs. pure crossover period responses.
Measured: Baseline and last day of inpatient stay.
Change in quality of life from baseline during exposures to contactants.
Compare common vs. pure crossover period responses.
Measured: Baseline and last day of inpatient stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Apr 2026
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AllergicStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Hirsh D Komarow, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271381
- Sponsor's protocol ID
- 10002257
- Other IDs
- 002257-I
- Status last verified
- 9 Sep 2026
- First submitted
- 6 Dec 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rinaldi AO, Korsfeldt A, Ward S, Burla D, Dreher A, Gautschi M, Stolpe B, Tan G, Bersuch E, Melin D, Askary Lord N, Grant S, Svedenhag P, Tsekova K, Schmid-Grendelmeier P, Mohrenschlager M, Renner ED, Akdis CA. Electrical impedance spectroscopy for the characterization of skin barrier in atopic dermatitis. Allergy. 2021 Oct;76(10):3066-3079. doi: 10.1111/all.14842. Epub 2021 May 15.
PubMed 33830511Zeldin J, Chaudhary PP, Spathies J, Yadav M, D'Souza BN, Alishahedani ME, Gough P, Matriz J, Ghio AJ, Li Y, Sun AA, Eichenfield LF, Simpson EL, Myles IA. Exposure to isocyanates predicts atopic dermatitis prevalence and disrupts therapeutic pathways in commensal bacteria. Sci Adv. 2023 Jan 6;9(1):eade8898. doi: 10.1126/sciadv.ade8898. Epub 2023 Jan 6.
PubMed 36608129Pat Y, Yazici D, D'Avino P, Li M, Ardicli S, Ardicli O, Mitamura Y, Akdis M, Dhir R, Nadeau K, Agache I, Ogulur I, Akdis CA. Recent advances in the epithelial barrier theory. Int Immunol. 2024 Apr 3;36(5):211-222. doi: 10.1093/intimm/dxae002.
PubMed 38227765Yazici D, Ogulur I, Pat Y, Babayev H, Barletta E, Ardicli S, Bel Imam M, Huang M, Koch J, Li M, Maurer D, Radzikowska U, Satitsuksanoa P, Schneider SR, Sun N, Traidl S, Wallimann A, Wawrocki S, Zhakparov D, Fehr D, Ziadlou R, Mitamura Y, Bruggen MC, van de Veen W, Sokolowska M, Baerenfaller K, Nadeau K, Akdis M, Akdis CA. The epithelial barrier: The gateway to allergic, autoimmune, and metabolic diseases and chronic neuropsychiatric conditions. Semin Immunol. 2023 Nov;70:101846. doi: 10.1016/j.smim.2023.101846. Epub 2023 Oct 4.
PubMed 37801907Akdis CA. Does the epithelial barrier hypothesis explain the increase in allergy, autoimmunity and other chronic conditions? Nat Rev Immunol. 2021 Nov;21(11):739-751. doi: 10.1038/s41577-021-00538-7. Epub 2021 Apr 12.
PubMed 33846604Ogulur I, Pat Y, Aydin T, Yazici D, Ruckert B, Peng Y, Kim J, Radzikowska U, Westermann P, Sokolowska M, Dhir R, Akdis M, Nadeau K, Akdis CA. Gut epithelial barrier damage caused by dishwasher detergents and rinse aids. J Allergy Clin Immunol. 2023 Feb;151(2):469-484. doi: 10.1016/j.jaci.2022.10.020. Epub 2022 Dec 1.
PubMed 36464527Sasaki M, Sundberg M, Frei R, Ferstl R, Heye KN, Willems EP, Akdis CA, Lauener R; CK-CARE Study Group; Roduit C. Electrical impedance spectroscopy detects skin barrier dysfunction in childhood atopic dermatitis. Allergy. 2024 Jan;79(1):142-152. doi: 10.1111/all.15895. Epub 2023 Sep 27.
PubMed 37753955Yadav M, Chaudhary PP, D'Souza BN, Ratley G, Spathies J, Ganesan S, Zeldin J, Myles IA. Diisocyanates influence models of atopic dermatitis through direct activation of TRPA1. PLoS One. 2023 Mar 6;18(3):e0282569. doi: 10.1371/journal.pone.0282569. eCollection 2023.
PubMed 36877675Whelan K, Bancil AS, Lindsay JO, Chassaing B. Ultra-processed foods and food additives in gut health and disease. Nat Rev Gastroenterol Hepatol. 2024 Jun;21(6):406-427. doi: 10.1038/s41575-024-00893-5. Epub 2024 Feb 22.
PubMed 38388570Galant SP, Komarow HD, Shin HW, Siddiqui S, Lipworth BJ. The case for impulse oscillometry in the management of asthma in children and adults. Ann Allergy Asthma Immunol. 2017 Jun;118(6):664-671. doi: 10.1016/j.anai.2017.04.009.
PubMed 28583260Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.
PubMed 24841846Redruello-Requejo M, Del Mar Blaya M, Gonzalez-Reguero D, Robas-Mora M, Arranz-Herrero J, Partearroyo T, Varela-Moreiras G, Penalba-Iglesias D, Jimenez-Gomez P, Reche-Sainz P. Cross-Sectional Comparative Analysis of Gut Microbiota in Spanish Adolescents with Mediterranean and Western Diets. Nutrients. 2025 Jan 22;17(3):388. doi: 10.3390/nu17030388.
PubMed 39940246
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins
- ClinicalTrials.gov ID
- NCT07271381
- Acronym / sponsor ID
- 10002257
- Conditions
- Allergic, Inflammatory
- Keywords
- Environmental Exposures, Skin barrier dysfunction, Skin impedance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Jan 2031 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
Study Description:
In this study, we aim to investigate whether there is a link between lifestyle exposures, inflammation, and disease by exposing participants to environments with real-world levels of common skin and hair products (eg, soaps, shampoos), a typical Western diet of processed food, and/or ubiquitous air exposures, and to environments with cleaner, more natural contactants and less processed food. Participants will spend up to 7 days as an inpatient in a controlled environment with the assigned exposures, and up to 7 days as an inpatient in a cleaner environment. We will collect a variety of biospecimens and data throughout the inpatient stays to identify changes in skin, gastrointestinal (GI), and airway survey parameters.
The study will consist of 2 stages with a crossover design in each stage. Stage 1 will be divided into 3 cohorts: one cohort to identify changes in skin, one for GI changes, and one for airway changes. Within each cohort, participants will be block randomized to spend up to 7 days in the inpatient unit with either the specifically assigned experimental (common) or control (pure) exposures. Within each of the 3 cohorts, the common exposures will target a specific organ system (skin, GI, or airway). After a brief washout period, participants will then crossover to the other targeted exposure (ie, from common to pure or vice versa), for an additional inpatient stay of up to 7 days. The findings from each participant s first inpatient stay will be compared to findings from their crossover second inpatient stay.
The data collected from Stage 1 may be used to clarify the survey parameters of participants enrolled into Stage 2, in which new participants will be randomized to all common exposure domains (skin + GI + airway) vs. pure (control) and then a crossover.
Objectives:
Stage 1 Primary Objectives:
- Cohort 1: Determine the effects of common vs. pure exposures on the skin in healthy volunteers.
- Cohort 2: Determine the effects of common vs. pure exposures on the GI tract in healthy volunteers.
- Cohort 3: Determine the effects of common vs. pure exposures on the airway in healthy volunteers.
Stage 1 Secondary Objective: Determine the combined effects of common vs. pure exposures on the skin, gut, and airway in healthy volunteers.
Stage 2 Primary Objective: Determine the combined effects of common vs. pure exposures on the skin, gut, and airway in healthy volunteers.
Endpoints:
Stage 1 Primary Endpoints:
- Cohort 1 (skin): The primary endpoint for the skin substudy is the skin impedance change response from the common environment (as a log geometric mean ratio [GMR]) minus the mean skin impedance change response from the pure environment (as a log GMR). For each crossover intervention period (common or pure), we measure the GMR as the ratio of the geometric mean (GM) of the average skin impedance measurements at the last day of the inpatient stay over the GM of the average skin impedance measurements at day 0 (baseline).
- 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 (a measure of metabolic diversity) measured on the gut microbiome.
- Cohort 3 (airway): The primary endpoint for the airway substudy is the airway maximum change response from the common environment (as the log of the GM of the maximum of the daily change response) minus the airway maximum change response from the pure environment. For each crossover intervention period (common or pure), we measure each individual s daily change response as airway resistance (R5) measured at each day of the inpatient stay over the R5 at day 0 (baseline).
Stage 1 Secondary Endpoints will compare common vs pure crossover period responses as follows:
- Cohort 1 (skin):
- Proportion of participants that experience a 30% reduction in skin impedance from admission to any time point during inpatient stay.
- Change in metabolic functional analysis and/or specific taxa of skin microbiome from admission to last day of the inpatient stay.
- Change in skin metabolomics by tape strip analysis during study exposure.
- Cohort 2 (GI):
- Change in metabolic functional analysis and/or specific taxa of gut microbiome.
- Change in diversity index, metabolic functional analysis, and/or specific taxa of oral microbiome.
- Cohort 3 (airway):
- Increase in R5 from admission to last day of inpatient stay by impulse oscillometry (IOS).
- All 3 Cohorts:
- Change in serum and/or intradermal fluid inflammatory markers during study exposure.
- Change in serum lipopolysaccharides (LPS) and bacterial translocation markers (a marker of GI barrier integrity) during study exposure.
- Change in quality of life from baseline during exposures to contactants.
- Changes in activity from baseline during study exposure.
- Change in sense of smell/taste during study exposure.
- Correlation of exposures with activity and/or symptoms.
Stage 2 Endpoint: Based on isolated exposures from single organ systems and randomization design in Stage 1, repeat primary and secondary endpoint responses of Stage 1.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Common Airway | Experimental | Other: Environmental ExposuresExposure to a sham air purifier, and wall art with foam and polyurethane. |
| Common Gastrointestinal | Experimental | Other: Environmental ExposuresExposure to an ultra processed diet. |
| Common Skin | Experimental | Other: Environmental ExposuresExposure to toothpaste, body wash, shampoo, and detergents containing sodium lauryl sulfate and other hazardous agents (commonly used likely toxic ingredients). |
| Pure Airway | Other | Other: Control ExposuresExposure to wall art without foam and polyurethane. |
| Pure Gastrointestinal | Other | Other: Control ExposuresExposure to a a minimally processed diet. |
| Pure Skin | Other | Other: Control ExposuresExposure to SLS-free and toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to provide informed consent.
- Age 18-80 years.
- Agreement to adhere to lifestyle considerations.
- Ability to exclusively adhere to UPD and MPD during inpatient stay.
- Ability to speak English.
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Diagnosis of atopic (physician-diagnosed asthma, AD, food allergy, chronic hives), autoimmune, metabolic, or chronic infectious or inflammatory diseases.
- Current or history of neoplastic disease within 5 years.
- 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).
- Current receipt of chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental ExposuresToothpaste, skin lotion, hand soap, body wash, laundry detergent, shampoo containing sodium lauryl sulfate (SLS), wall art with foam and polyurethane, and processed food. | Other | Common Airway, Common Gastrointestinal, Common Skin |
| Control ExposuresSLS-free, toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets, a minimally processed diet, and wall art without foam and polyurethane. | Other | Pure Airway, Pure Gastrointestinal, Pure Skin |
Primary outcome
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
9 secondary outcomes
Change metabolic functional analysis, and/or specific taxa of skin microbiome.
Time frame: Baseline and completion of inpatient stay.
Change in skin metabolomics by tape strip analysis during study exposure.
Time frame: Baseline and completion of inpatient stay.
Change in metabolic functional analysis, and/or specific taxa of gut microbiome.
Time frame: Baseline and completion of inpatient stay.
Change in diversity index, metabolic functional analysis, and/or specific taxa of oral microbiome. Perform pair-wise and p-crest analysis.
Time frame: Baseline and completion of inpatient stay.
Increase in airway resistance (using R5 or R5-R20) from admission to last day (or the maximum of the daily measurements) of inpatient stay by impulse oscillometry (IOS).
Time frame: Baseline and completion of inpatient stay.
Change in FEV1, FVC using spirometry.
Time frame: Baseline and last day of inpatient stay.
Change in serum and/or intradermal fluid inflammatory markers.
Time frame: Baseline and last day of inpatient stay.
Change in serum lipopolysaccharides (LPS) and bacterial translocation markers (a marker of GI barrier integrity).
Time frame: Baseline and last day of inpatient stay.
Change in quality of life from baseline during exposures to contactants.
Time frame: Baseline and last day of inpatient stay.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 33830511Rinaldi AO, Korsfeldt A, Ward S, Burla D, Dreher A, Gautschi M, Stolpe B, Tan G, Bersuch E, Melin D, Askary Lord N, Grant S, Svedenhag P, Tsekova K, Schmid-Grendelmeier P, Mohrenschlager M, Renner ED, Akdis CA. Electrical impedance spectroscopy for the characterization of skin barrier in atopic dermatitis. Allergy. 2021 Oct;76(10):3066-3079. doi: 10.1111/all.14842. Epub 2021 May 15.
- Background: PubMed 36608129Zeldin J, Chaudhary PP, Spathies J, Yadav M, D'Souza BN, Alishahedani ME, Gough P, Matriz J, Ghio AJ, Li Y, Sun AA, Eichenfield LF, Simpson EL, Myles IA. Exposure to isocyanates predicts atopic dermatitis prevalence and disrupts therapeutic pathways in commensal bacteria. Sci Adv. 2023 Jan 6;9(1):eade8898. doi: 10.1126/sciadv.ade8898. Epub 2023 Jan 6.
- Background: PubMed 38227765Pat Y, Yazici D, D'Avino P, Li M, Ardicli S, Ardicli O, Mitamura Y, Akdis M, Dhir R, Nadeau K, Agache I, Ogulur I, Akdis CA. Recent advances in the epithelial barrier theory. Int Immunol. 2024 Apr 3;36(5):211-222. doi: 10.1093/intimm/dxae002.
- Background: PubMed 37801907Yazici D, Ogulur I, Pat Y, Babayev H, Barletta E, Ardicli S, Bel Imam M, Huang M, Koch J, Li M, Maurer D, Radzikowska U, Satitsuksanoa P, Schneider SR, Sun N, Traidl S, Wallimann A, Wawrocki S, Zhakparov D, Fehr D, Ziadlou R, Mitamura Y, Bruggen MC, van de Veen W, Sokolowska M, Baerenfaller K, Nadeau K, Akdis M, Akdis CA. The epithelial barrier: The gateway to allergic, autoimmune, and metabolic diseases and chronic neuropsychiatric conditions. Semin Immunol. 2023 Nov;70:101846. doi: 10.1016/j.smim.2023.101846. Epub 2023 Oct 4.
- Background: PubMed 33846604Akdis CA. Does the epithelial barrier hypothesis explain the increase in allergy, autoimmunity and other chronic conditions? Nat Rev Immunol. 2021 Nov;21(11):739-751. doi: 10.1038/s41577-021-00538-7. Epub 2021 Apr 12.
- Background: PubMed 36464527Ogulur I, Pat Y, Aydin T, Yazici D, Ruckert B, Peng Y, Kim J, Radzikowska U, Westermann P, Sokolowska M, Dhir R, Akdis M, Nadeau K, Akdis CA. Gut epithelial barrier damage caused by dishwasher detergents and rinse aids. J Allergy Clin Immunol. 2023 Feb;151(2):469-484. doi: 10.1016/j.jaci.2022.10.020. Epub 2022 Dec 1.
- Background: PubMed 37753955Sasaki M, Sundberg M, Frei R, Ferstl R, Heye KN, Willems EP, Akdis CA, Lauener R; CK-CARE Study Group; Roduit C. Electrical impedance spectroscopy detects skin barrier dysfunction in childhood atopic dermatitis. Allergy. 2024 Jan;79(1):142-152. doi: 10.1111/all.15895. Epub 2023 Sep 27.
- Background: PubMed 36877675Yadav M, Chaudhary PP, D'Souza BN, Ratley G, Spathies J, Ganesan S, Zeldin J, Myles IA. Diisocyanates influence models of atopic dermatitis through direct activation of TRPA1. PLoS One. 2023 Mar 6;18(3):e0282569. doi: 10.1371/journal.pone.0282569. eCollection 2023.
- Background: PubMed 38388570Whelan K, Bancil AS, Lindsay JO, Chassaing B. Ultra-processed foods and food additives in gut health and disease. Nat Rev Gastroenterol Hepatol. 2024 Jun;21(6):406-427. doi: 10.1038/s41575-024-00893-5. Epub 2024 Feb 22.
- Background: PubMed 28583260Galant SP, Komarow HD, Shin HW, Siddiqui S, Lipworth BJ. The case for impulse oscillometry in the management of asthma in children and adults. Ann Allergy Asthma Immunol. 2017 Jun;118(6):664-671. doi: 10.1016/j.anai.2017.04.009.
- Background: PubMed 24841846Malvehy J, Hauschild A, Curiel-Lewandrowski C, Mohr P, Hofmann-Wellenhof R, Motley R, Berking C, Grossman D, Paoli J, Loquai C, Olah J, Reinhold U, Wenger H, Dirschka T, Davis S, Henderson C, Rabinovitz H, Welzel J, Schadendorf D, Birgersson U. Clinical performance of the Nevisense system in cutaneous melanoma detection: an international, multicentre, prospective and blinded clinical trial on efficacy and safety. Br J Dermatol. 2014 Nov;171(5):1099-107. doi: 10.1111/bjd.13121. Epub 2014 Oct 19.
- Background: PubMed 39940246Redruello-Requejo M, Del Mar Blaya M, Gonzalez-Reguero D, Robas-Mora M, Arranz-Herrero J, Partearroyo T, Varela-Moreiras G, Penalba-Iglesias D, Jimenez-Gomez P, Reche-Sainz P. Cross-Sectional Comparative Analysis of Gut Microbiota in Spanish Adolescents with Mediterranean and Western Diets. Nutrients. 2025 Jan 22;17(3):388. doi: 10.3390/nu17030388.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hirsh D Komarow, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Exposures in people with Allergic and Inflammatory, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodi L Blake, R.N. ((301) 605-2896, jodi.blake@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07271381, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.