Clinical trial NCT05587036: Effects of Rifaximin on Gut Microbiota and Emotion
Official title: A Randomized, Triple-blind, Placebo-controlled Study on the Effect of Rifaximin on Psychobiological Functions in Healthy Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Healthy Volunteers
Stress
Fear
Keywords: Rifaximin
Anti-Bacterial Agents
Stress
Fear
Inflammation
Short-Chain Fatty Acid
Microbiota-Gut-Brain Axis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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

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 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.

Primary outcomes:
measure: Stress sensitivity (biological)
timeFrame: Throughout study completion, on average 1 year
measure: Stress sensitivity (psychological)
timeFrame: Throughout study completion, on average 1 year
measure: Fear (biological)
timeFrame: Throughout study completion, on average 1 year
measure: Fear (psychological)
timeFrame: Throughout study completion, on average 1 year
Secondary outcomes:
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Throughout study completion, on average 1 year
measure: Perceived Stress Scale (PSS)
timeFrame: Throughout study completion, on average 1 year
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Throughout study completion, on average 1 year
measure: Leiden Index of Depression Sensitivity (LEIDS-R)
timeFrame: Throughout study completion, on average 1 year
measure: State-Trait Anxiety Inventory, State Anxiety Subscale (STAI-S)
timeFrame: Throughout study completion, on average 1 year
measure: Brain response to stress
timeFrame: Throughout study completion, on average 1 year
Other outcomes:
measure: Fecal gut microbiota profile
timeFrame: Throughout study completion, on average 1 year
measure: Serum short-chain fatty acid levels
timeFrame: Throughout study completion, on average 1 year
measure: Cytokine levels
timeFrame: Throughout study completion, on average 1 year
measure: C-reactive protein levels
timeFrame: Throughout study completion, on average 1 year
measure: Heart rate variability
timeFrame: Throughout study completion, on average 1 year
measure: Heart rate
timeFrame: Throughout study completion, on average 1 year
measure: Blood pressure
timeFrame: Throughout study completion, on average 1 year
measure: Brain metabolite concentration
timeFrame: Throughout study completion, on average 1 year
Locations:
city: Leuven
country: Belgium
facility: UZ/KU Leuven
Study officials:
affiliation: KU Leuven
name: Lukas Van Oudenhove, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Kristin Verbeke, Pharm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Boushra Dalile, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VIB-KU Leuven
name: Jeroen Raes, PhD
role: PRINCIPAL_INVESTIGATOR
References: