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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517808-11-00
Acronym
S66407
Enrollment
60
Registered
2024-11-04
Start date
2022-10-01
Completion date
Unknown
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Brief summary

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)

Detailed description

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

Interventions

DRUGTARGAXAN 550 mg Filmtabletten
DRUGThe placebo tablets are white to off-white tablets with a mean weight of 488 mg
DRUGminimum hardness of 50 N and a mean thickness of about 5.7 mm. The following formula will be used in the manufacturing of the placebo tablets: Ingredient Amount/tablet Lactose monohydrate 320 mg Carmellose Sodium 10 mg Corn starch 70 mg Cellulose microcrystalline 55 mg Sillicium dioxide anhydrous 20 mg Magnesium stearate 13 mg Total tablet weight 488 mg

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026