NCT05587036 Effects of Rifaximin on Gut Microbiota and Emotion
| NCT ID | NCT05587036 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-02-02 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-02-02 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 1. Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder 2. Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardize 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 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. Previous or current substance/alcohol dependence or abuse (\>2 units per day or 14 units per week) 10. One or more diagnoses based on the mini international neuropsychiatric interview (MINI-S) 11. One or more diagnoses based on ROME IV for gastrointestinal disorders 12. Smoking 13. Night-shift work 14. Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.) 15. Use of pre- or probiotics within one month preceding the study 16. Previous experience with any of the tasks used in the study (not including questionnaires) 17. Color vision deficiency (colorblindness) 18. Magnetic Resonance Imaging (MRI) contraindications, including claustrophobia, severe back problems, conditions that would interfere with MRI scanning (e.g. cochlear implant, metal fragments in eyes, metallic body inclusion, or other metal implanted in the body), and if the participant does not want to be informed of incidental findings that might be found during imaging.
Contact & Investigator
Lukas Van Oudenhove, MD, PhD
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT05587036 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 50 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05587036 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05587036 currently recruiting?
Yes, NCT05587036 is actively recruiting participants. Contact the research team at lukas.vanoudenhove@kuleuven.be for enrollment information.
Where is the NCT05587036 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05587036 clinical trial?
NCT05587036 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Lukas Van Oudenhove, MD, PhD at KU Leuven. The trial plans to enroll 60 participants.