Experimental study with healthy participants recruited from the general population
Conditions
Interventions
Trade Name: TARGAXAN
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
KU Leuven
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy male participants - Age 18-50 years - BMI 18.5-25 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder - Participation in any other interventional Trial with an investigational medicinal product (IMP) or device - Hypersensitivity to the active substance rifaximin, to any rifamycin (e.g. rifampicin or rifabutin) or any of the excipients - Current or recent medication use - Use of antibiotics within three months preceding the study - Current or recent infection (e.g. common cold, influenza, COVID-19, etc.) - Previous or current substance/alcohol dependence or abuse (>2 units per day or 14 units per week) - One or more diagnoses based on the mini international neuropsychiatric interview - One or more diagnoses based on ROME IV for gastrointestinal disorders - Smoking - Night-shift work - Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.) - Use of pre- or probiotics within one month preceding the study - Previous experience with any of the tasks used in the study - Color vision deficiency (colorblindness) Additional exclusion criteria for participants partaking in the brain imaging part of the study: 1. Claustrophobia or too much uneasiness in limited spaces (in order to tolerate confinement during the scanning procedures). 2. Severe back problems interfering with lying in supine position in the scanner with no movement for long durations. 3. Any condition that would interfere with MRI studies (e.g., cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, and metallic body inclusion or other metal implanted in the body which may interfere with MRI scanning). To check this, participants fill out a checklist before the procedure (see Appendix). 4. If the participant invokes that he does not want to be informed of eventual pathology that might be found during imaging (invokes the “right not to know”) Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled/randomized in the Trial and will be identified on the Screening Log as Screen Failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test whether rifaximin-induced gut microbiota alteration will attenuate psychobiological responses towards stress and fear in healthy men.;Secondary Objective: To investigate whether rifaximin exerts its effect on psychobiological function through the modulation of short-chain fatty acids, inflammation, brain activity under stress, and changes in particular brain metabolites.;Primary end point(s): Psychobiological readouts related to stress and fear tasks, including salivary cortisol levels, subjective visual analogue scale (VAS) stress reports, skin conductance levels, and expectancy of dangerous stimulus (expectancy ratings);Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mediators: Gut microbiota profile, heart rate variability, short-chain fatty acids (SCFA) levels, inflammatory marker profile (cytokine panel and C-reactive protein levels), fMRI BOLD responses to stress, and brain metabolite concentration;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated at the end of the study | — |
Countries
Belgium
Contacts
Public ContactLukas Van Oudenhove
KU Leuven
Outcome results
None listed