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| Name | Class |
|---|---|
| Region Örebro County | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stimulated serotonergic activity | Experimental |
| |
| unstimulated serotonergic activity | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serotonergic stimulation | Other | Increase of serotonergic activity by a single oral administration of 10 mg Escitalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), packed in a coloured hydroxypropylmethylcellulose capsule. |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in functional brain response pattern to the barostat in stimulated compared to unstimulated serotonergic activity | functional magnetic resonance imaging | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in functional brain response pattern to the Montreal Imaging Stress Task between stimulated and unstimulated serotonergic activity | functional magnetic resonance imaging | 1 week |
| Differences in functional brain response pattern to the Emotional Attention Task between stimulated and unstimulated serotonergic activity |
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Inclusion criteria for the irritable bowel syndrome group:
Exclusion criteria for the irritable bowel syndrome group:
Inclusion criteria for healthy group:
Exclusion criteria for the healthy group:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Brummer, Prof. | Örebro University, Region Örebro County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University, Region Örebro County | Örebro | 70182 | Sweden |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| no serotonergic stimulation | Other | Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose. |
|
functional magnetic resonance imaging |
| 1 week |
| 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 | functional magnetic resonance imaging | 1 week |
| 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 | functional magnetic resonance imaging | 1 week |
| 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 | functional magnetic resonance imaging | 1 week |
| D004066 | Digestive System Diseases |