Immun-mediated sickness symptoms
Conditions
Interventions
Group 1: Single injection of endotoxin (E. coli, 0113:H10
i.v., 0.8 ng/kg body weight) to induce a systemic inflammatory response
single administration of an anti-inflammatory drug (Ibuprofen, oral, 400 mg), verbal manipulation of treatment expectations (augmented).
Group 2: Single injection of endotoxin (E. coli, 0113:H10
single administration of an anti-inflammatory drug (Ibuprofen, oral, 400 mg), verbal manipulation of treatment expectations (neutral).
Group 3: Single injection of endotoxin (E. coli, 0113:H10
i.v., 0.4 ng/kg body weight) to induce a systemic inflammatory response
single administration of an anti-inflammatory drug (Ibuprofen, oral, 400 mg), verbal manipulation of treatment expectations (augmented).
Group 4: Single injection of endotoxin (E. coli, 0113:H10
single administration of an anti-inflammatory drug (Ibuprofen, oral, 400 mg), verbal manipulation of treatment expectations (neutral).
Sponsors
Universitätsklinikum Essen, Institut für Didaktik in der Medizin
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Healthy male and female participants aged 18 to 50 years.
Exclusion criteria
Exclusion criteria: Acute or chronic physical illnesses (e.g., gastrointestinal diseases, liver and kidney diseases, cardiovascular diseases, diabetes mellitus, obesity). Pathological laboratory values (e.g., CRP). Regular use of medications (except for oral contraception). Contraindications for ibuprofen. Indications of psychiatric disorders according to DSM-V criteria based on validated screening instruments (particularly depression and anxiety disorders). MRI-specific exclusion criteria (anxiety disorders, particularly claustrophobia, metallic implants, metal-containing tattoos, etc.). Additional exclusion criteria for female participants: pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Sickness symptoms (physical and psychological symptoms) using validated questionnaires. Measurements are taken at baseline, then every 15 minutes for the first 3 hours, every 30 minutes for the next 2 hours, once per hour for the last 2 hours, as well as 24 hours and 7 days after the LPS injection (questionnaires), and at baseline and 2 hours after LPS injection (algometry)." | — |
Secondary
| Measure | Time frame |
|---|---|
| "Pressure pain sensitivity using algometry (baseline and every 15 minutes for the first 3 hours). Treatment and symptom expectations using questionnaires (baseline, then every 30 minutes after injection). Repeated measurements of the following parameters (at baseline as well as at 1, 2, 3, 4, 6, and 24 hours and 7 days after LPS injection): Concentration of pro- and anti-inflammatory cytokines and neuroendocrine parameters in plasma or serum and saliva, T-cell and B-cell function at the level of cytokine secretion and proliferation, blood pressure, heart rate, body temperature." | — |
Countries
Germany
Contacts
Public ContactSven Benson
Universitätsklinikum Essen, Institut für Didaktik in der Medizin
Outcome results
None listed