Effects of rifaximin on gut bacteria and emotional responses
A Randomized, Triple-blind, Placebo-controlled Study on the Effect of Rifaximin on Psychobiological Functions in Healthy Men
This study is testing if the antibiotic rifaximin can change gut bacteria and affect how healthy men respond to stress and fear.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05587036 on ClinicalTrials.gov |
What this trial studies
This interventional trial investigates how rifaximin, an antibiotic, alters gut microbiota and its subsequent effects on stress sensitivity and fear-related processes in healthy men. Participants will be randomly assigned to receive either rifaximin or a placebo for two weeks, with a focus on understanding the psychobiological changes induced by the treatment. The study employs a triple-blind design to ensure unbiased results, and aims to identify factors that may mediate or moderate these changes.
Who should consider this trial
Good fit: Ideal candidates are healthy male volunteers aged 18-50 with a BMI between 18.5-25 kg/m2.
Not a fit: Patients with a history of neurological, psychiatric, gastrointestinal, or endocrine disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the relationship between gut health and emotional well-being, potentially leading to new treatments for stress and anxiety.
How similar studies have performed: While the relationship between gut microbiota and mental health is an emerging field, this specific approach using rifaximin is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven
- UZ/KU Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Lukas Van Oudenhove, MD, PhD — KU Leuven
- Study coordinator: Lukas Van Oudenhove, MD, PhD
- Email: lukas.vanoudenhove@kuleuven.be
- Phone: +32 16 33 01 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.