NCT03551080

Brief Summary

In this randomized double blind cross-over study 8 healthy persons were injected with 0.8 ng/kg body weight lipopolysaccharide (LPS) /endotoxin and placebo at two different occasions. The aim was to investigate how pain sensitivity and health perception change in response to an acute immune activation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
Last Updated

June 11, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 29, 2018

Last Update Submit

May 29, 2018

Conditions

Sickness Behavior

Keywords

Sickness behaviorCytokinesPsychoneuroimmunology

Outcome Measures

Primary Outcomes (1)

  • Change in interoceptive vs exteroceptive focus

    Rating of concordance of heartbeat vs signal and change in tone of signal

    7 hours

Secondary Outcomes (4)

  • Change in self-rated health

    7 hours

  • Change in pain perception

    7 hours

  • Change in facial apparence

    2 hours

  • Change in gait

    2 h

Study Arms (2)

Endotoxin

ACTIVE COMPARATOR

0.8 ng lipopolysaccharide/kg body weight injection

Biological: Lipopolysaccharide

Placebo

PLACEBO COMPARATOR

Saline injection

Biological: Placebo

Interventions

LipopolysaccharideBIOLOGICAL

Endotoxin at 0.8 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)

Also known as: Endotoxin, LPS
Endotoxin
PlaceboBIOLOGICAL

Saline administered intravenously

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • Diagnosed physiological or psychiatric disease
  • Needle anxiety or blood phobia
  • Regular medication (excluding contraceptive pill)
  • Infection in the last two weeks
  • Pregnancy or breastfeeding
  • Smoking
  • Excessive alcohol use
  • Body mass index in the range of obesity (\>30 kg/m2) or underweight (\<18.5 kg/m2)
  • Invisible veins in the antecubital area of the arms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Illness Behavior

Interventions

LipopolysaccharidesEndotoxins

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

GlycoconjugatesCarbohydratesPolysaccharides, BacterialPolysaccharidesLipidsAntigens, BacterialAntigensBiological FactorsBacterial ToxinsToxins, Biological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 29, 2018

First Posted

June 11, 2018

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 11, 2018

Record last verified: 2018-05