Actively Recruiting
Randomized, Triple-Blind, Placebo-Controlled Study of Rifaximin's Effects on Psychobiological Functions in Healthy Men
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
Researchers are investigating how rifaximin, an antibiotic, affects gut bacteria and psychobiological functions such as stress sensitivity and fear in healthy men aged 18 to 50 years. This randomized, triple-blind, placebo-controlled trial aims to understand the impact of changes in gut microbiota caused by rifaximin on psychological and biological responses related to stress and fear. The study also seeks to explore factors that might influence these psychobiological changes. Participants are randomly assigned to one of two groups: one group receives rifaximin (550 mg) tablets twice daily for two weeks, while the other group receives placebo tablets on the same schedule. The intervention is delivered orally in a parallel group design over the two-week period. The study carefully monitors participants during and after this treatment phase. Throughout the approximately one-year study duration, researchers measure biological and psychological responses to stress and fear to assess the effects of rifaximin. Participants undergo various assessments, including psychobiological tests and questionnaires. Safety and adherence are closely monitored to ensure participant well-being and the integrity of the study findings.
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
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Trial Site Locations
Total: 1 location
1
UZ/KU Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
L
Lukas Van Oudenhove, MD, PhD
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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