NCT01143480Recruiting
Study of the Effect of Innate on the Inflammatory Response to Endotoxin
Study of the Effect of Innate Immunity on the Inflammatory Response to Endotoxin
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 725 (estimated)
- First submitted
- 11 Jun 2010
- Start date
- 30 Jul 2012
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Diseases
- Asthma
- NCT number
- NCT01143480
What you commit to
- Study type: Observational
- Planned participants: 725
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 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
Other illness
- Current treatment for cancer with chemotherapy or radiation
- Confirmed or suspected immunosuppressive or immunodeficient condition
- 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.
Other
- 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
Criteria the registry did not label
- 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).
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIEHS Clinical Research Unit (CRU) Coordinator of this site? Confirm its status | Research Triangle Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.