Study of the Effect of Innate on the Inflammatory Response to Endotoxin

Launched by NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) · Jun 11, 2010

Keywords

ClinConnect Summary

This clinical trial is studying how certain genes and proteins in our blood cells react to environmental factors that might lead to inflammation. Inflammation is a natural response by our immune system, but when it becomes chronic, it can contribute to conditions like asthma, heart disease, metabolic syndrome, and some cancers. The goal is to understand these responses better, which could help in finding new treatments for these illnesses.

The study is looking for healthy volunteers aged 18 to 45 who are willing to participate. If you qualify, you’ll have a single visit lasting about 45 to 60 minutes where you’ll answer some questions, undergo a brief health check, and donate a small blood sample for research. To be eligible, you must not have taken certain medications recently, be in good health, and be able to fast before your appointment. This trial is currently recruiting participants, so if you or someone you know fits the criteria and is interested, it could be a valuable opportunity to contribute to important medical research.

Gender

ALL

Eligibility criteria

• * 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.