Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

002257-I

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Pregnant Women;
Children;
Neonates;
Fetuses;
Adults who are or may become unable to consent

Keywords

Environmental Exposures;
Skin barrier dysfunction;
Skin impedance

Recruitment Keyword(s)

None

Condition(s)

Allergic;
Inflammatory

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Environmental Exposures
Other: Control Exposures

Supporting Site

National Institute of Allergy and Infectious Diseases

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

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. Positive Phadiatop test.

3. Current or history of neoplastic disease within 5 years.

4. 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).

5. Current receipt of chemotherapy.

6. HIV, hepatitis B, or hepatitis C infection.

7. Receipt of any vaccine within 1 month prior to enrollment.

8. Receipt of oral antibiotics within 3-6 months prior to enrollment.

9. Use of topical, oral, or parental corticosteroids within 1 month prior to enrollment.

10. Participation in another treatment or intervention study within 3 months prior to enrollment.

11. Currently pregnant or lactating.

12. Currently smoking or vaping.

13. Any other condition or intercurrent illness deemed by the investigators to be of potential risk to the participant or validity of study results.


Citations:

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, M(SqrRoot)(Delta)hrenschlager 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. PMID: 33830511.

Zeldin 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. PMID: 36608129; PMCID: PMC9821876.

Pat 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. PMID: 38227765; PMCID: PMC10989673.

Yazici 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, Br(SqrRoot) ggen 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. PMID: 37801907.

Akdis 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. PMID: 33846604.

Ogulur I, Pat Y, Aydin T, Yazici D, R(SqrRoot) ckert 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. PMID: 36464527.

Sasaki 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. PMID: 37753955.

Yadav 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. PMID: 36877675; PMCID: PMC9987805.

Whelan 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. PMID: 38388570.

Galant 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. PMID: 28583260; PMCID: PMC5486406.

Malvehy 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. PMID: 24841846; PMCID: PMC4257502.

Redruello-Requejo M, Del Mar Blaya M, Gonz(SqrRoot)(Degree)lez-Reguero D, Robas-Mora M, Arranz-Herrero J, Partearroyo T, Varela-Moreiras G, Penalba-Iglesias D, Jim(SqrRoot)(Copyright)nez-G(SqrRoot)>=mez 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. PMID: 39940246; PMCID: PMC11820480.

Contacts:

Principal Investigator

Referral Contact

For more information:

Hirsh D. Komarow, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 6D44A
10 CENTER DR
BETHESDA MD 20892
(301) 594-2197
komarowh@mail.nih.gov
Hirsh D. Komarow, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 6D44A
10 CENTER DR
BETHESDA MD 20892
(301) 594-2197
komarowh@mail.nih.gov
Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT07271381
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