Individual Differences in Acute Response to Experimental Inflammation: Microcirculatory Changes and Psychological Predictors

NCT06618716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-05-08

No results posted yet for this study

Summary

The physiological and behavioral responses to inflammatory vary greatly between individuals. The knowlegde about what causes these differences is sparse but plausible explanations are variations in sensitivity to peripheral inflammation. The goal of the study is to understand microcirculatory changes in skin and their possible correlation with conventional measurements of sickness and disease in humans. A better understanding of possible psychological predictors of sickness behaviour is also warranted as it may affect the results.

The general aim of the study is to assess microcirculatory changes in skin of the face, chest, hands and feet using different optical imaging techniques, and to identify psychological predictors in the acute behavioral response to experimentally induced inflammation. The participants are healthy volunteers in the age of 18-40 years of both sex/genders. The main questions to answer are:

1. How do acute inflammation change microcirculation in the skin as measured by temperature, red blood cell concentration, blood flow and spectral changes correlated with fluids and other proteins.
2. Can a stronger behavioral response to experimental endotoxemia be predicted by psychological factors of the individuals?

It is a blinded with-in subject, crossover design where the participants will receive placebo-injection with saline on one study day and LPS-injection the other study day in a randomized order.

Participants will on the study days

* Fill in psychometric questionnaires
* Be measured with bio-optical imaging methods at regular intervalls.
* Be monitored with regular medical parameters such as blood pressure, oxygen saturation, puls etc When the volunteers feel recovered and the medical staff are confident of the recovery the volunteers will be discharged.

Conditions

Interventions

BIOLOGICAL

endotoxin escherichia coli (E. coli) lipopolysaccharide (LPS)

Intravenous administration of endotoxin (0.8 ng/kg body weight)

OTHER

Placcebo

Placebo injection of 0.9% NaCl

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER
  • Stockholm University

    collaborator OTHER
  • University Hospital, Linkoeping

    lead OTHER

Principal Investigators

  • Rani Toll, PhD · Department of Emergency Medicine in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-03-11
Completion
2025-03-11

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618716 on ClinicalTrials.gov