Effect of Serotonergic Stimulation on the Gut-brain Axis

Not Applicable

Active, not recruiting

• Conditions: Irritable Bowel Syndrome; Healthy
• Interventions: Other: serotonergic stimulation; Other: no serotonergic stimulation

• Registration Number: NCT03920410
• Lead Sponsor: Örebro University, Sweden

Brief Summary

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.

Detailed Description

In this double-blinded, randomized, cross-over study, irritable bowel syndrome subjects (n = 40) and healthy controls (n = 20) will perform an emotional and the arithmetic task and receive visceral stimuli (by using a barostat) while placed in a functional magnetic resonance imaging scanner respectively during two different states, a) after oral administration of 10 mg Escitalopram, a well-known drug classified as Selective Serotonin Reuptake Inhibitor, packed in a coloured hydroxypropylmethylcellulose capsule, and b) during oral administration of a placebo, in a double-blinded randomized cross-over fashion. Background characteristics will be collected.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Study Start: 2019-04-24
• Primary Completion: 2022-03-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
stimulated serotonergic activity	serotonergic stimulation	-
unstimulated serotonergic activity	no serotonergic stimulation	-

Primary Outcome Measures

Name	Time	Method
Differences in functional brain response pattern to the barostat in stimulated compared to unstimulated serotonergic activity	1 week	functional magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
Differences in functional brain response pattern to the barostat stimulus paradigm between irritable bowel syndrome patients and healthy controls for stimulated and unstimulated serotonergic activity	1 week	functional magnetic resonance imaging
Differences in functional brain response pattern to the Montreal imaging stress task (MIST) between irritable bowel syndrome patients and healthy controls for stimulated and unstimulated serotonergic activity	1 week	functional magnetic resonance imaging
Differences in functional brain response pattern to the Montreal Imaging Stress Task between stimulated and unstimulated serotonergic activity	1 week	functional magnetic resonance imaging
Differences in functional brain response pattern to the Emotional Attention Task between stimulated and unstimulated serotonergic activity	1 week	functional magnetic resonance imaging
Differences in functional brain response pattern to the emotional attention task (EAT) between irritable bowel syndrome patients and healthy controls for stimulated and unstimulated serotonergic activity	1 week	functional magnetic resonance imaging

Trial Locations

Locations (1)

Örebro University, Region Örebro County; 🇸🇪 Örebro, Sweden