Effects of Rifaximin on Gut Microbiota and Emotion

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Oct 17, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called rifaximin affects gut bacteria and emotions in healthy men. The study aims to understand if rifaximin can influence how we feel and respond to stress and fear. It is a Phase 2 trial, meaning it is in the early stages of testing to see if the drug works safely in people. The trial is currently recruiting male participants aged between 18 and 50 who are generally healthy, do not have any intestinal or psychological issues, and have a body mass index (BMI) between 18.5 and 25.

If you qualify and decide to participate, you will be randomly assigned to receive either rifaximin or a placebo (a substance that looks like the drug but has no active ingredients). The study will involve some tests and procedures to monitor your health and how you respond during the trial. It's important to note that participants must not have any history of certain medical conditions, recent infections, or be taking certain medications, as this could affect the study's results. Overall, this trial is a chance to contribute to our understanding of how gut health may relate to emotions and stress responses.

Gender

MALE

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.