Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00820989
Other study ID # 0220013432
Secondary ID GM64351-01
Status Completed
Phase Phase 1
First received January 9, 2009
Last updated May 20, 2014
Start date February 2000
Est. completion date February 2011

Study information

Verified date May 2014
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 -

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Rutgers-RWJMS New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physiological, Hematological, Immunological Responses .5-24 hours after Endotoxin administration No
See also
  Status Clinical Trial Phase
Completed NCT02277080 - The Immune and Endocrine Systems in Chronic Non-cancer Patients Treated With Opioids
Active, not recruiting NCT05026242 - Effects of Almond Consumption on Innate and Adaptive Immune System N/A
Completed NCT04701502 - Efficacy and Safety of Viusid and Asbrip in Hospitalized Patients With Mild and Moderate COVID-19 Phase 2
Terminated NCT05133128 - An Experimental Medicine Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Solid Tumours. N/A
Recruiting NCT05792137 - Postprandial Monocyte Study N/A
Completed NCT05329337 - Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia N/A
Completed NCT06263686 - Evaluation of the Effects of Routine Intake of Fresh vs- Pasteurized Yoghurt on the Immune System in Healthy Adults N/A
Recruiting NCT04772794 - Immunologic Effect of Fraction of Inspired Oxygen N/A
Recruiting NCT06312423 - Safety and Pharmacokinetics of IMT504, an Immunomodulator and Tissue Repair Inducer Phase 1
Completed NCT00753402 - The Effects of Epinephrine in Endotoxemia in Normal Volunteers Phase 1
Completed NCT05221996 - Minimal-Dose Resistance Training for Improving sIgA and Cortisol N/A
Completed NCT04275440 - Effects of Caloric Restriction and Exercise on Body Weight, Immune Function, and Intestinal Flora N/A
Recruiting NCT06109337 - Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity Disorder
Recruiting NCT05648136 - Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage N/A
Completed NCT06190379 - Aromatherapy for Upper Respiratory Health N/A
Recruiting NCT05334888 - Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach
Completed NCT00730626 - Dose Response Study of a Fermented Yogurt on the Immune System and Gut Health N/A
Recruiting NCT06400212 - CytoHealth - A Study of the Inflammatory Response to Exercise N/A