Healthy subjects
Conditions
Interventions
Group 1: The experimental group receives a transvagus nerve stimulation (tVNS). The stimulation is performed with a maximum of 25 Hz, starts 30 minutes before LPS application and ends one hour after l
Sponsors
Medizinischen FakultätUniversitätsklinikum Bonn
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: - Signed consent form - Age > 18 years and < 45 years - male gender - Caucasian origin.
Exclusion criteria
Exclusion criteria: - smokers - known predisposition to constipation or diarrhea - surgery or trauma associated with increased blood loss or transfusion of erythrocyte concentrates - Blood donation in the last four weeks - taking an immunosuppressive or immunomodulatory medication in the last six months - Regular medication intake - Anamnestically known or indications for cardiovascular pre-existing conditions - vasovagal or orthostatic syncope in the last 12 months - resting pulse 100/min - Blood pressure systolic > 150 mmHg or 12 G/l or clinically detectable infection - feverish infection in the last two weeks before screening - swallowing disorders - Aspiration event in the anamnesis - Stomach Bezoar in the anamnesis - suspected or known strictures, fistulas or physiological/mechanical GI obstruction - any abdominal surgery in the last three months - abdominal surgical operations in anamnesis (exception: appendectomy, cholecystectomy or minimally invasive procedures) - chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis) - Sigmadiverticulitis in the last three months - diabetes mellitus - Diseases of the adrenal medulla - Subjects after splenectomy - Inability to understand the significance and consequences of this clinical trial. - Participation in another clinical trial involving the taking of an investigational product or the use of a medical device up to 30 days prior to participation in that clinical trial - known abuse of medication, drugs or alcohol - Lack of suitability of the volunteer to participate in the study in accordance with the investigator's instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the mean value of the points reached in the Kox score over the measurement period (with and without tVNS). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are defined as follows: 1 a ) Comparison of intestinal transit time and motility of GI tract (measured by SmartPill® over pH, intraluminal pressure, number of peristaltic waves and temperature during gastrointestinal passage) between study arms 1 b) Analysis of the tightness of the intestinal mucosa barrier via the lactuolose/annitol ratio in urine using the Enzychrom™ Intestinal Permeability Assay in comparison between the study arms 2) comparison of physiological parameters influenced by the autonomic nervous system (including body temperature, heart rate, blood pressure, heart rate variability) between study arms 3) Comparison of AEs/SAEs and ADEs/SADEs between the study arms 4) Comparison of mood and motivation of the test persons by means of questionnaires HADS, BDI, STAI, STAT, SSS, Sickness-Score and STADI as well as multidimensional questionnaire between the study arms at different points in time. 5 a) Analysis of the plasma concentration of pro- and antiinflammatory parameters (in particular TNF-a, IL 6, IL 8, IL 10, IL 1ß, HMGB-1) as well as changes in the blood count at different points in time 5 b) Comparison of cytokines induced by PRR ligands (especially type I IFN/ TNF- a/ IL-1 ß/ IL-6 IL-18) in ex vivo stimulated immune cells before beginning tVNS stimulation, before LPS administration and 6 h after beginning tVNS stimulation as well as at final visit | — |
Countries
Germany
Contacts
Public ContactCornelius J. van Beekum
Universitätsklinikum BonnKlinik und Poliklinik für Allgemein-, Viszeral-, und Thorax- und Gefäßchirurgie
Outcome results
None listed