THREAT: Testing Harms Related to Exposure to Allergenic and Epithelial Toxins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Environmental Exposures
Other interventionToothpaste, 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
Other interventionSLS-free, toxin free toothpaste, body wash, shampoo, detergents, non-synthetic clothing, and sheets, a minimally processed diet, and wall art without foam and polyurethane.
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Common AirwayExperimental treatment 1 intervention
Group B: Common GastrointestinalExperimental treatment 1 intervention
Group C: Common SkinExperimental treatment 1 intervention
Group D: Pure AirwayOther 1 intervention
Group E: Pure GastrointestinalOther 1 intervention
Group F: Pure SkinOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and completion of inpatient stay2
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.
Time frame
Baseline and completion of inpatient stay3
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
Time frame
Baseline and completion of inpatient stay4
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.
Time frame
Baseline and completion of inpatient staySecondary outcomes
1
Change metabolic functional analysis, and/or specific taxa of skin microbiome.
Compare common vs. pure crossover period responses.
Time frame
Baseline and completion of inpatient stay.2
Change in skin metabolomics by tape strip analysis during study exposure.
Compare common vs. pure crossover period responses.
Time frame
Baseline and completion of inpatient stay.3
Change in metabolic functional analysis, and/or specific taxa of gut microbiome.
Compare common vs. pure crossover period responses.
Time frame
Baseline and completion of inpatient stay.4
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.
Time frame
Baseline and completion of inpatient stay.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov