MoodBugs_Rifaximin
EU CTIS ID: 2024-517808-11-00
What this study is testing
To test whether rifaximin-induced gut microbiota alteration will attenuate psychobiological responses towards stress and fear in healthy men.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Proficiency in English and/or Dutch 3. Healthy with no intestinal and/or psychological complaints 4. Access to a -18°C freezer (i.e. ordinary household freezer) 5. Male participants 6. Age 18-50 years 7. BMI 18.5-25 kg/m2
You likely can't join if
- 1. Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endorcrine disorder 2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial 4. Participation in an interventional Trial with an investigational medicinal product (IMP) or device 5. Hypersensitivity to the active substance rifaximin, to any rifamycin (e.g. rifampicin or rifabutin) or any of the excipients (see Section 5.1) 6. Current or recent medication use 7. Use of antibiotics within three months preceding the study 8. Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.) 9. Recent (1-month) vaccination (e.g. flu shot, SARS-COV-2 vaccine, etc) 10. Previous or current substance/alcohol dependence or abuse (>2 units per day or 14 units per week) 11. One or more diagnoses based on the mini international neuropsychiatric interview 12. One or more diagnoses based on ROME IV for gastrointestinal disorders 13. Smoking 14. Night-shift work 15. Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.) 16. Use of pre- or probiotics within one month preceding the study 17. Previous experience with any of the tasks used in the study (not including questionnaires) 18. 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”)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.