Inflammation and the Host Response to Injury (In Healthy Volunteers) (Mono)

Rutgers The State University of New Jersey

Status and phase: Completed; Phase 1

Conditions: Immune System

Treatments: Biological: Endotoxin, Lipopolysaccharide, LPS

Study type: Interventional

Funder types: Other

Identifiers

NCT00820989

0220013432

GM64351-01

Details and patient eligibility

About

The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

Full description

The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.

Enrollment: 116 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.
• Written informed consent prior to the performance of any study related procedure.

Exclusion criteria

• History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
• Recent history of alcohol or drug abuse
• Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures
• Exposure to any experimental agent or procedure within 30 days of study
• Pregnancy or breast feeding
• Prior exposure to endotoxin in an experimental setting -

Trial design

116 participants in 1 patient group

A

Experimental group

Description:

Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration).

Treatment:

Biological: Endotoxin, Lipopolysaccharide, LPS