Actively Recruiting
Effects of Rifaximin on Gut Microbiota and Emotion
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-12-20
60
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.
CONDITIONS
Official Title
Effects of Rifaximin on Gut Microbiota and Emotion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained before screening
- Proficiency in English and/or Dutch
- Healthy with no intestinal or psychological complaints
- Access to a household freezer that can reach -18°C
- Male participants
- Age between 18 and 50 years
- Body mass index (BMI) between 18.5 and 25 kg/m2
You will not qualify if you...
- History of neurological, psychiatric, gastrointestinal, or endocrine disorders
- Any condition that might risk participant safety or study compliance
- Prior or current treatments that could affect safety or study integrity
- Participation in another interventional trial involving medicinal products or devices
- Allergy to rifaximin, rifamycin antibiotics, or any excipients
- Current or recent use of medications
- Use of antibiotics within three months before the study
- Current or recent infection within one month (e.g., cold, influenza, COVID-19)
- History or current substance or alcohol dependence or abuse exceeding 2 units per day or 14 units per week
- Diagnoses from mini international neuropsychiatric interview (MINI-S)
- Diagnoses based on ROME IV for gastrointestinal disorders
- Smoking
- Night-shift work
- Following special diets such as vegan, vegetarian, weight-loss, lactose-free, or gluten-free
- Use of prebiotics or probiotics within one month before the study
- Previous experience with study tasks excluding questionnaires
- Color vision deficiency (colorblindness)
- Contraindications for MRI including claustrophobia, severe back problems, metal implants, or unwillingness to be informed about incidental MRI findings
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ/KU Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
L
Lukas Van Oudenhove, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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