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Recruiting Phase 2, Phase 3 NCT05587036

Effects of Rifaximin on Gut Microbiota and Emotion

Trial Parameters

Condition Healthy Volunteers
Sponsor Universitaire Ziekenhuizen KU Leuven
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 60
Sex MALE
Min Age 18 Years
Max Age 50 Years
Start Date 2023-02-02
Completion 2025-07
Interventions
RifaximinPlacebo

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 rifa

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