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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 100 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 1 visit
- Procedures mentioned: Blood draws, Physical exams, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "A maximum of 200 mLs of blood will be obtained from each participant during one visit lasting approximately 1-1.5 hours."
- "Blood monocytes will be isolated from the donated blood samples and cultured to obtain macrophages."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how genes and proteins in blood cells respond to things in the environment. It is for healthy volunteers who give a blood sample during one visit lasting 45 to 60 minutes. The study overview lists ages 18 to 45, but the detailed rules say age 18 or older.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, though the study overview lists ages 18 to 45.
- Be able to understand the study and sign a form agreeing to take part.
- Be able to travel to the study clinic.
- Be willing and able to fast—not eat—after midnight before your visit.
- Feel well and be able to do normal activities. Any long-term condition, such as diabetes or high blood pressure, must be treated and under control.
Who can't join
- Used pain medicines such as ibuprofen, naproxen, or Tylenol within 5 days, or cholesterol-lowering drugs called statins within 30 days before the visit.
- Use medicines that weaken or change the immune system, including steroid medicines; have a known or suspected weak immune system; or are getting chemotherapy or radiation for cancer. The study doctor may review medicine use case by case.
- Had a stomach, bowel, or breathing illness, including a cold or allergies, within 5 days before the visit.
- Smoked or chewed tobacco, or used electronic cigarettes, within 2 weeks before the visit. For those giving urine, a tobacco-exposure test above 200 ng/mL meets this rule.
- Had more than 2 standard alcoholic drinks in the 24 hours before the visit. The study defines one standard drink as 15 grams of alcohol.
- Weigh less than 110 pounds (50 kg), or have long-term kidney disease.
- Have a temperature above 37.6°C; blood pressure below 90/50 or above 170/95; or a pulse below 50 or above 100 beats per minute.
- Are pregnant or may be pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
NC
- NIEHS Clinical Research Unit (CRU) · Research Triangle Park, NC 27709NIEHS Join A Study Recruitment Group · Study contact · 855-696-4347 · myniehs@nih.govMore trials in Research Triangle Park