Environmental Exposures for Allergy and Inflammation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how everyday exposure to common substances affects health, focusing on allergic and inflammatory conditions. Participants will stay in two environments: one with minimal chemical exposure (Control Exposures) and another with typical environmental exposures. Researchers will compare the health effects of these environments using various tests and samples. Healthy individuals aged 18 to 80, who can adhere to specific diets and product use during the study, may be eligible to join. As an unphased trial, this study allows participants to contribute to important research on environmental health impacts.
Will I have to stop taking my current medications?
The trial requires that you do not use medications that affect skin, gut, or airway symptoms, or those that impact the skin or gut microbiome. If you are on such medications, you may need to stop them before joining the study. Oral birth control is allowed if used consistently for 3-6 months prior to enrollment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that certain environmental chemicals can affect health. For the Common Airway group, studies have found that inhaling particles like PM10 can damage the lungs and cause breathing problems. Air purifiers that fail to remove these particles may not alleviate these issues.
For the Common Gastrointestinal group, consuming large amounts of ultra-processed foods has been linked to gut problems and other health issues. These foods can increase the risk of diseases like inflammatory bowel disease and other long-term conditions.
In the Common Skin group, products containing sodium lauryl sulfate (SLS) can irritate the skin. Frequent use of SLS is known to cause rashes and skin damage.
Overall, these exposures carry some reported risks. However, the study aims to understand how everyday exposures affect health, with careful monitoring of participants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how everyday environmental exposures might influence allergies and inflammation. Unlike traditional treatments that often rely on medications or topical creams to manage symptoms, this approach investigates the impact of common household and dietary exposures. The trial examines various settings, such as exposure to ultra-processed diets, potentially harmful air quality, and common skin care ingredients like sodium lauryl sulfate. By understanding these environmental effects, researchers hope to identify alternative strategies for managing allergies and inflammation, potentially leading to more natural preventive measures.
What evidence suggests that this trial's treatments could be effective for allergy and inflammation?
This trial will compare the effects of different environmental exposures on allergies and inflammation. Research has shown that the environment significantly impacts allergies and inflammation. For skin health, studies find that pollution can damage the skin and worsen allergies. Chemicals like sodium lauryl sulfate, found in many everyday products, irritate the skin and cause inflammation. Participants in this trial will be exposed to either common skin products containing such chemicals or SLS-free and toxin-free alternatives.
Regarding the gut, evidence suggests that air pollution increases the risk of stomach and intestinal diseases. This occurs partly because it alters the gut microbiome, the collection of bacteria in the intestines, and raises allergy risks. In this trial, participants will follow either an ultra-processed diet or a minimally processed diet to assess the impact on gut health.
For the respiratory system, air pollution is linked to increased airway irritation and allergy symptoms. Exposure to common pollutants can worsen asthma and allergic reactions, highlighting how environmental factors affect respiratory health. Participants will experience either exposure to a sham air purifier and wall art with foam and polyurethane or wall art without these materials to evaluate respiratory effects.
In summary, this trial will investigate how everyday environmental exposures can worsen allergies and inflammation in the skin, gut, and airways.678910Who Is on the Research Team?
Hirsh D Komarow, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Are You a Good Fit for This Trial?
This trial is for healthy volunteers interested in how common environmental exposures like skin and hair products, processed foods, and air pollutants compare to more natural environments. Participants will be exposed to these conditions as inpatients for up to 7 days with a crossover design.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1 - Inpatient Stay (Common or Pure Exposure)
Participants are exposed to either common or pure environments targeting skin, GI, or airway for up to 7 days.
Washout Period
A brief washout period between crossover interventions.
Stage 1 - Crossover Inpatient Stay
Participants crossover to the alternate exposure (common to pure or vice versa) for up to 7 days.
Stage 2 - Combined Exposure
New participants are randomized to all common exposure domains (skin + GI + airway) vs. pure (control) and then a crossover.
Follow-up
Participants are monitored for safety and effectiveness after treatment.
What Are the Treatments Tested in This Trial?
Interventions
- Control Exposures
- Environmental Exposures
Trial Overview
The study tests the effects of typical Western lifestyle exposures versus cleaner alternatives on skin, gastrointestinal (GI) tract, and airway health. It involves two stages: first testing each system separately then all together after a washout period.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Exposure to SLS-free and toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets.
Exposure to a a minimally processed diet.
Exposure to wall art without foam and polyurethane.
Exposure to toothpaste, body wash, shampoo, and detergents containing sodium lauryl sulfate and other hazardous agents (commonly used likely toxic ingredients).
Exposure to an ultra processed diet.
Exposure to a sham air purifier, and wall art with foam and polyurethane.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
Citations
Environmental exposures and mechanisms in allergy and ...
This Review highlights epidemiologic and mechanistic evidence linking environmental exposures to the development and exacerbation of allergic airway responses.
Urban Lifestyle and Climate‐Driven Environmental ...
Evidence suggests these environmental exposures increase allergen loads and profoundly influence immune system function. Air pollutants and ...
Impact of air pollution on patients with AR: Current ...
In the upper airways, controlled exposure of healthy individuals to VOCs showed increased nasal symptoms score for irritation and odor intensity and an increase ...
Environmental exposures contribute to respiratory and allergic ...
This research evaluates whether environmental exposures (pesticides and smoke) influence respiratory and allergic outcomes in women living in a tropical, ...
Environmental and occupational allergies
Indoor and outdoor air pollutants trigger airway inflammation and increase the severity of asthma. Diesel exhaust particles increase the production of IgE ...
Effects of the Use of Air Purifier on Indoor Environment and ...
5) is known to adversely affect the respiratory system when inhaled, inducing airway inflammation and other respiratory conditions [3,4,5,6].
Portable air cleaner use and biomarkers of inflammation
Portable air cleaners that reduce PM 2.5 exposure can decrease concentrations of inflammatory biomarkers associated with cardiovascular disease.
Indoor air pollution and airway health
We provide a review of emerging literature spanning the past 3 years and relating indoor air exposures to airway health.
Inhalable Particulate Matter and Health (PM2.5 and PM10)
Those with a diameter of 10 microns or less (PM10) are inhalable into the lungs and can induce adverse health effects.
Effectiveness of Air Filters in Allergic Rhinitis: A Systematic ...
Air filters help reduce allergen exposure by effectively regulating the levels of pollens, HDMs, pet allergens, and PM in indoor environments [ ...
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