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CompletedNCT00820989MonoUpdated May 21, 2014

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

A Phase 1 interventional study of Endotoxin, Lipopolysaccharide, LPS in Immune System, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-21.

Sponsored by Rutgers, The State University of New Jersey · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
116
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Immune System

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Keywords

  • Healthy Immune System
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 116 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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 -
05

Study design

Phase
Phase 1
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    A

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

    Biological: Endotoxin, Lipopolysaccharide, LPS

Interventions

  • BiologicalEndotoxin, Lipopolysaccharide, LPS

    Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\~5 minutes)

    Also known as: Sodium Chloride Solution

06

What researchers measure

Primary outcomes

  1. Physiological, Hematological, Immunological Responses

    Time frame: .5-24 hours after Endotoxin administration

07

Study locations

1 site
  • Rutgers-RWJMS
    New Brunswick, New Jersey 08850, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00820989
Lead sponsor
Rutgers, The State University of New Jersey
Responsible party
Sponsor
First posted
Jan 12, 2009
Start date
Feb 2000
Primary completion
Feb 2011
Completion
Feb 2011
Last update
May 21, 2014

Study contacts

Siobhan Corbett, MD
principal investigator · Rutgers-RWJMS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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