Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Recruiting · NCT01143480 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
View the official record on ClinicalTrials.gov →What this trial is about
Background: \- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers. Objectives: \- To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * The study will involve one visit of 45 to 60 minutes. * Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking. * Participants will provide a blood sample for research purposes.
Who can take part
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 is running
1 location listed across 1 US state.
- NIEHS Clinical Research Unit (CRU) - Research Triangle Park, North Carolina, United States