Effects of Rifaximin on Gut Microbiota and Emotion

NCT05587036 | Recruiting Phase 2

• 2 other identifiers: S664072021-006814-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men.

Conditions

Healthy Volunteers; Stress; Fear

Keywords

Rifaximin; Anti-Bacterial Agents; Stress; Fear; Inflammation; Short-Chain Fatty Acid; Microbiota-Gut-Brain Axis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (6)

• Positive and Negative Affect Schedule (PANAS)

  Throughout study completion, on average 1 year

• Perceived Stress Scale (PSS)

  Throughout study completion, on average 1 year

• Gastrointestinal Symptom Rating Scale (GSRS)

  Throughout study completion, on average 1 year

• Leiden Index of Depression Sensitivity (LEIDS-R)

  Throughout study completion, on average 1 year

• State-Trait Anxiety Inventory, State Anxiety Subscale (STAI-S)

  Throughout study completion, on average 1 year

Other Outcomes (8)

• Fecal gut microbiota profile

  Throughout study completion, on average 1 year

• Serum short-chain fatty acid levels

  Throughout study completion, on average 1 year

• Cytokine levels

  Throughout study completion, on average 1 year

Study Arms (2)

Rifaximin

EXPERIMENTAL

Rifaximin oral tablets, 550 mg, twice daily, two-weeks

Drug: Rifaximin

Placebo

PLACEBO COMPARATOR

Placebo oral tablets, twice daily, two-weeks

Dietary Supplement: Placebo

Interventions

Rifaximin DRUG

Rifaximin oral tablet, 550 mg, twice daily, two-weeks

Also known as: Targaxan

Rifaximin

Placebo DIETARY_SUPPLEMENT

Placebo oral tablet, twice daily, two-weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Proficiency in English and/or Dutch
• Healthy with no intestinal and/or psychological complaints
• Access to a -18°C freezer (i.e. ordinary household freezer)
• Male participants
• Age 18-50 years
• BMI 18.5-25 kg/m2

You may not qualify if:

• Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder
• Any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol
• Any prior or concomitant treatment(s) that might jeopardize the participant's safety or that would compromise the integrity of the Trial
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• Hypersensitivity to the active substance rifaximin, to any rifamycin (e.g. rifampicin or rifabutin) or any of the excipients
• Current or recent medication use
• Use of antibiotics within three months preceding the study
• Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.)
• Previous or current substance/alcohol dependence or abuse (\>2 units per day or 14 units per week)
• One or more diagnoses based on the mini international neuropsychiatric interview (MINI-S)
• One or more diagnoses based on ROME IV for gastrointestinal disorders
• Smoking
• Night-shift work
• Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.)
• Use of pre- or probiotics within one month preceding the study

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ/KU Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Lukas Van Oudenhove, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Kristin Verbeke, Pharm, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Boushra Dalile, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Jeroen Raes, PhD

  VIB-KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Van Oudenhove, MD, PhD

CONTACT

+32 16 33 01 47; lukas.vanoudenhove@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected and analysed.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 19, 2022
• Study Start: February 2, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will become available upon publication with no time limitations.
• Access Criteria: The data will be publicly available.

Locations

BE (1)