NCT05587036

Effects of Rifaximin on Gut Microbiota and Emotion

A Randomized, Triple-blind, Placebo-controlled Study on the Effect of Rifaximin on Psychobiological Functions in Healthy Men

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Healthy Volunteers
• Stress
• Fear

Interventions

Type	Name	Description
DRUG	Rifaximin	Rifaximin oral tablet, 550 mg, twice daily, two-weeks
DIETARY_SUPPLEMENT	Placebo	Placebo oral tablet, twice daily, two-weeks

Timeline

• Start date: 2023-02-02
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-10-19
• Last updated: 2024-12-20

Locations

1 site across 1 country: Belgium