Examining how the body responds to endotoxin exposure
Study of the Effect of Innate Immunity on the Inflammatory Response to Endotoxin
National Institutes of Health Clinical Center (CC) · NCT01143480
This study is testing how healthy people's immune systems react to a substance called endotoxin by looking at their blood samples to see if it helps us understand links to conditions like asthma and cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 725 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Drugs / interventions | infliximab, chemotherapy, radiation, prednisone |
| Locations | 1 site (Research Triangle Park, North Carolina) |
| Trial ID | NCT01143480 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy volunteers aged 18 to 45 who can provide informed consent and meet specific health criteria.
Not a fit: Patients with chronic conditions such as diabetes or high blood pressure that are not well-controlled may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how innate immunity influences chronic diseases, leading to better prevention and treatment strategies.
How similar studies have performed: Other studies have shown success in examining the role of innate immunity in inflammatory responses, suggesting that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Research Triangle Park, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma, Atherosclerosis, Metabolic Syndrome, Insulin Resistance, Cancer, Endotoxin, Innate Immunity, Natural History