Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2023-02-02
2025-07-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Rifaximin
Rifaximin oral tablets, 550 mg, twice daily, two-weeks
Rifaximin
Rifaximin oral tablet, 550 mg, twice daily, two-weeks
Placebo
Placebo oral tablets, twice daily, two-weeks
Placebo
Placebo oral tablet, twice daily, two-weeks
Interventions
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Rifaximin
Rifaximin oral tablet, 550 mg, twice daily, two-weeks
Placebo
Placebo oral tablet, twice daily, two-weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
MALE
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Lukas Van Oudenhove
Principal Investigator
Principal Investigators
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Lukas Van Oudenhove, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Kristin Verbeke, Pharm, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Boushra Dalile, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Jeroen Raes, PhD
Role: PRINCIPAL_INVESTIGATOR
VIB-KU Leuven
Locations
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UZ/KU Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Lukas Van Oudenhove, MD, PhD
Role: primary
Other Identifiers
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2021-006814-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
S66407
Identifier Type: -
Identifier Source: org_study_id