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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006814-35 | EudraCT Number |
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A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental | Rifaximin oral tablets, 550 mg, twice daily, two-weeks |
|
| Placebo | Placebo Comparator | Placebo oral tablets, twice daily, two-weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Rifaximin oral tablet, 550 mg, twice daily, two-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stress sensitivity (biological) | Biological stress sensitivity is measured by quantifying cortisol levels (ng/ml) from multiple saliva samples taken before, during, and after a stress task performed during the pre-intervention and post-intervention visit. | Throughout study completion, on average 1 year |
| Stress sensitivity (psychological) | Psychological stress sensitivity is measured through subjective stress reports of the participants using the visual analogue scale (VAS). VAS scorings are taken before, during, and after a stress task performed during the pre-intervention and post-intervention visit. | Throughout study completion, on average 1 year |
| Fear (biological) | Fear-related processes will be explored using a computerized task. Biological fear response is measured using skin conductance, and a skin conductance response (μS) is calculated . | Throughout study completion, on average 1 year |
| Fear (psychological) | Fear-related processes will be explored using a computerized task. Psychological fear response is measured subjectively by asking participants to indicate their expectancy score of an aversive stimulus. | Throughout study completion, on average 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Affect Schedule (PANAS) | Assessing ratings on the subscales of PANAS, positive and negative affect, before and after intervention. PA subscale scores range between 10-50, with higher scores indicating better outcome. NA subscale scores range between 10-50, with higher scores indicating worse outcome. | Throughout study completion, on average 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal gut microbiota profile | Assessing gut microbiota profile before and after intervention | Throughout study completion, on average 1 year |
| Serum short-chain fatty acid levels | Quantification of serum SCFA (μM) before and after intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukas Van Oudenhove, MD, PhD | Contact | +32 16 33 01 47 | lukas.vanoudenhove@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Lukas Van Oudenhove, MD, PhD | KU Leuven | Principal Investigator |
| Kristin Verbeke, Pharm, PhD | KU Leuven | Principal Investigator |
| Boushra Dalile, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ/KU Leuven | Recruiting | Leuven | 3000 | Belgium |
IPD that underlie results in a publication will be made available to other researchers with all identifying information removed.
The data will become available upon publication with no time limitations.
The data will be publicly available.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected and analysed.
| Placebo | Dietary Supplement | Placebo oral tablet, twice daily, two-weeks |
|
| Perceived Stress Scale (PSS) | Assessing ratings on PSS before and after intervention. PSS scores range between 0-40 with higher scores indicating worse outcome. | Throughout study completion, on average 1 year |
| Gastrointestinal Symptom Rating Scale (GSRS) | Assessing ratings on the subscales of GSRS and its total score before and after intervention. It has 5 subscales (Reflux, Diarrhea, Constipation, Abdominal Pain, and Indigestion Syndrome). Subscale scores range from 1 to 7 and higher scores indicates a worse outcome. | Throughout study completion, on average 1 year |
| Leiden Index of Depression Sensitivity (LEIDS-R) | Assessing ratings on the subscales of LEIDS-R and its total score before and after intervention. This is a self-report on cognitive reactivity comprised of 34 items with six subscales. Hopelessness/suicidality; Acceptance/Coping; Aggression; Control/Perfectionism; Risk Aversion; Rumination. | Throughout study completion, on average 1 year |
| State-Trait Anxiety Inventory, State Anxiety Subscale (STAI-S) | Assessing ratings on the momentary (state) anxiety subscale of STAI before and after intervention. This is a self-report comprised of 20 questions specifically for state anxiety, rated on a 4-point scale. State anxiety is rated with anxiety absent and anxiety present questions. Anxiety absent questions constitute the absence of anxiety in a statement like, "I feel secure." Anxiety present questions represent the presence of anxiety in a statement like "I feel worried." The 4-point scale are as follows: 1 'not at all', 2 'somewhat', 3 'moderately so', and 4 'very much so'. | Throughout study completion, on average 1 year |
| Brain response to stress | Brain response (brain oxygenation level-dependent signals) to a fMRI-adapted stress task will be measured before and after intervention | Throughout study completion, on average 1 year |
| Throughout study completion, on average 1 year |
| Cytokine levels | Quantification of inflammatory cytokines (pg/ml) before and after intervention | Throughout study completion, on average 1 year |
| C-reactive protein levels | Quantification of C-reactive protein levels (ng/ml) before and after intervention | Throughout study completion, on average 1 year |
| Heart rate variability | Assessing heart rate variability (ms) with ECG before and after intervention | Throughout study completion, on average 1 year |
| Heart rate | Assessing heartbeat (bpm) with a blood pressure monitor before and after intervention | Throughout study completion, on average 1 year |
| Blood pressure | Assessing blood pressure (systolic/diastolic mmHg) with a blood pressure monitor before and after intervention | Throughout study completion, on average 1 year |
| Brain metabolite concentration | Relative quantification of brain metabolites (mmol/L) using 1H-Magnetic Resonance Spectroscopy before and after intervention | Throughout study completion, on average 1 year |
| KU Leuven |
| Principal Investigator |
| Jeroen Raes, PhD | VIB-KU Leuven | Principal Investigator |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |