Examining how the body responds to endotoxin exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the role of innate immunity in the inflammatory response to endotoxin by analyzing blood samples from healthy volunteers. Participants aged 18 to 45 will undergo a brief screening and provide blood samples for research purposes. The study aims to explore how specific genes and proteins in blood cells react to environmental factors, potentially linking these responses to chronic conditions like asthma and cancer. Approximately 1450 participants will be recruited from the Environmental Polymorphism Registry in North Carolina.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:
* Male or female 18 years of age or older
* Participants must be able to understand and provide written informed consent to participate in the study
* Participants must be able to travel to the CRU
* Willing and able to fast after midnight the night prior to their study appointment.
* Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).

EXCLUSION CRITERIA:

* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)
* Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit
* Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)
* Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)
* Current treatment for cancer with chemotherapy or radiation
* Confirmed or suspected immunosuppressive or immunodeficient condition
* GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies
* Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \>200 ng/mL at visit)
* Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit
* Body weight \< 50 kg (\<110 lbs)
* Temperature \> 37.6 C; blood pressure \< 90/50 mm Hg or \> 170/95 mm Hg; pulse rate \< 50 or \>100 beats/minute
* Pregnant or suspected pregnancy
* Chronic Kidney Disease

The PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.

Where it's running

• NIEHS Clinical Research Unit (CRU)
  Research Triangle Park, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Michael B Fessler, M.D. — National Institute of Environmental Health Sciences (NIEHS)
• Study coordinator: NIEHS Join A Study Recruitment Group
• Email: myniehs@nih.gov
• Phone: (855) 696-4347

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.