Effects of Rifaximin on Gut Microbiota and Emotion

Phase 3RecruitingNCT05587036

Universitaire Ziekenhuizen KU Leuven60 enrolled

Overview

A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.

This study is a randomized, triple-blind, placebo-controlled, interventional trial aiming to elucidate the impact of rifaximin-induced gut microbiota alteration to the psychobiological functioning of healthy men. The intervention will be performed in a parallel group design where one group will receive rifaximin (Targaxan 550 mg) twice daily for two weeks (treatment arm), while the other group will receive placebo (placebo arm). Primary objective: to test the effect of rifaximin on stress sensitivity and fear-related processes Secondary objective: to determine the mediating and/or moderating factors that underlie rifaximin-induced psychobiological changes

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers Stress Fear

Interventions

RifaximinDRUG

Rifaximin oral tablet, 550 mg, twice daily, two-weeks

PlaceboDIETARY_SUPPLEMENT

Placebo oral tablet, twice daily, two-weeks

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UZ/KU Leuven

Leuven, Belgium

RECRUITING

Outcomes

Primary Outcomes

Stress sensitivity (biological)

Biological stress sensitivity is measured by quantifying cortisol levels (ng/ml) from multiple saliva samples taken before, during, and after a stress task performed during the pre-intervention and post-intervention visit.