Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
60
Countries
1
Sites
1
Healthy volunteers
To test whether rifaximin-induced gut microbiota alteration will attenuate psychobiological responses towards stress and fear in healthy men.
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Phenomena and Processes [G] - Physiological processes [G07], Psychiatry and Psychology [F] - Psychological Phenomena [F02], Phenomena and Processes [G] - Microbiological Phenomena [G06]
- Trial duration
- 1 Oct 2022 → 15 Oct 2025
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517808-11-00
- EudraCT number
- 2021-006814-35
- ClinicalTrials.gov
- NCT05587036
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To test whether rifaximin-induced gut microbiota alteration will attenuate psychobiological responses towards stress and fear in healthy men.
Secondary objectives 1
- To investigate whether rifaximin exerts its effect on psychobiological function through the modulation of short-chain fatty acids, inflammation,brain activity under stress, and changes in particular brain metabolites.
Conditions and MedDRA coding
Healthy volunteers
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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
- 1. Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endorcrine disorder 2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol 3. Any prior or concomitant treatment(s) that might jeopardise 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 (see Section 5.1) 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. Recent (1-month) vaccination (e.g. flu shot, SARS-COV-2 vaccine, etc) 10. Previous or current substance/alcohol dependence or abuse (>2 units per day or 14 units per week) 11. One or more diagnoses based on the mini international neuropsychiatric interview 12. One or more diagnoses based on ROME IV for gastrointestinal disorders 13. Smoking 14. Night-shift work 15. Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.) 16. Use of pre- or probiotics within one month preceding the study 17. Previous experience with any of the tasks used in the study (not including questionnaires) 18. Color vision deficiency (colorblindness) Additional exclusion criteria for participants partaking in the brain imaging part of the study: 1. Claustrophobia or too much uneasiness in limited spaces (in order to tolerate confinement during the scanning procedures). 2. Severe back problems interfering with lying in supine position in the scanner with no movement for long durations. 3. Any condition that would interfere with MRI studies (e.g., cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, and metallic body inclusion or other metal implanted in the body which may interfere with MRI scanning). To check this, participants fill out a checklist before the procedure (see Appendix). 4. If the participant invokes that he does not want to be informed of eventual pathology that might be found during imaging (invokes the “right not to know”)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Psychobiological readouts related to stress and fear tasks, including salivary cortisol levels, subjective visual analogue scale (VAS) stress reports, skin conductance levels, and expectancy of dangerous stimulus (expectancy ratings)
Secondary endpoints 1
- Gut microbiota profile, heart rate variability, SCFA levels, inflammatory marker profile (cytokine panel and C-reactive protein levels), fMRI BOLD responses to stress, and brain metabolite concentration
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD2018091 · Product
- Active substance
- Rifaximin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1100 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- A07AA11 — RIFAXIMIN
- Marketing authorisation
- BE433151
- MA holder
- NORGINE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL USE
- Max daily dose
- 1100 mg milligram(s)
- Max total dose
- 2400 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Lukas Van Oudenhove
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Liene Bervoets
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2022-10-01 | 2025-10-15 | 2022-10-01 | 2025-10-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517808-11-00 | 6 |
| Recruitment arrangements (for publication) | L2_Recruitment Flyer_ENG_NL_merged 2024-517808-11-00 | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_ENG 2024-517808-11-00 | 5 |
| Subject information and informed consent form (for publication) | L1_ICF_NL 2024-517808-11-00 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Rifaximin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_DE_2024-517808-11-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_FR_2024-517808-11-00 | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2024-517808-11-00 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-24 | Belgium | Acceptable 2024-10-31
|
2024-11-04 |