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Effect of Serotonergic Stimulation on the Gut-brain Axis

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion date: Dec 2024 to Dec 2025v8
  2. Minor Study completion date: Dec 2023 to Dec 2024v7
  3. Minor Study completion date: Dec 2022 to Dec 2023v6
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 58
    • Primary completion date changed from estimate of Jan 2022 to Mar 31, 2022
    • Site details revised
    v5
  5. Notable Primary completion date: Dec 2020 to Jan 2022
    • Study completion date: Dec 2021 to Dec 2022
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Study description revisedv3
  2. Minor Start date changed from estimate of Apr 2019 to Apr 24, 2019v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Selective serotonin reuptake inhibitors increase the level of serotonin. This study will use functional magnetic resonance imaging to examine how subjects with, and without, irritable bowel syndrome patients respond to serotonergic stimulation. Brain activation during emotional and arithmetic tasks and during visceral pain will be measured after serotonergic stimulation using the oral administration of Escitalopram (10 mg). The investigators will further integrate background parameters of the irritable bowel syndrome subjects and healthy controls (such as microbiota composition, genetic markers of serotonergic and inflammatory pathways, intestinal permeability, state of mood and visceral sensitivity) with the responses to the various challenges on the level of functional brain imaging. These responses may reveal a 'footprint' of the individual gut-brain axis function. Analyses of these individual footprints in multiple subjects with and without irritable bowel syndrome may reveal biosignatures characterising certain groups of patients according to specific gut-brain signalling response patterns. These biosignatures may be used to develop an individualised treatment algorithm for irritable bowel syndrome therapy.
Trial Details
NCT Number NCT03920410
Lead Sponsor Örebro University, Sweden
Collaborators: Region Örebro County
Conditions
(from sponsor)
Healthy, Irritable Bowel Syndrome
Related terms Irritable Bowel Syndrome
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov