HealthyNCT03920410
Effect of Serotonergic Stimulation on the Gut-brain Axis
A study testing serotonergic stimulation and no serotonergic stimulation in people with Healthy and Irritable Bowel Syndrome, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Irritable Bowel Syndrome
- What is being tested?
- serotonergic stimulation and no serotonergic stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects fulfill Rome IV diagnostic criteria for irritable bowel syndrome and pain frequency for at least 1 day per week in the last 12 weeks
- Males or females aged 18-65 years
- Signed informed consent
- Males and females aged 18-65 years of age
- Signed informed consent
Who cannot join
- Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (< 12 weeks), antibiotics (< 12 weeks)
- Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics)
- Diagnosis of major psychiatric or somatic disease other than part of irritable bowel syndrome
- Suicidal tendencies according to Montgomery Åsberg Depression Ratings Scale and/or clinical judgment
- Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test, and/or clinical judgment
- Recent (< 4 weeks) intake of proton pump inhibitors (e.g., omeprazole)
Show all 50Show fewer
- Epilepsy
- Cerebral bleeding or history of cerebral bleeding
- Pregnancy or breastfeeding (will be asked)
- Claustrophobia
- Smoking or using tobacco including snuff
- Dominant left-hand
- Medical implant (e.g., pacemaker)
- Aneurysm clips in the head
- Shunts in the head
- Grenade-splinter or metal-splinter in the body (e.g., eyes)
- Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
- Comprehensive tooth-implants or prothesis
- Operated in the head
- Operated in the heart
- Swallowed a video-capsule
- Non-corrected astigmatism
- Regular intake of antiinflammatory medication (including non-steroidal antiinflammatory drugs)
- Visual defect without possibility to use lenses during functional magnetic resonance imaging scanning
- Any other reason the investigator feels the subject is not suitable for participation in the study
- Concurrent or recent history of gastrointestinal disorders or any somatic disorder
- Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (< 12 weeks), antibiotics (< 12 weeks)
- Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics)
- Concurrent psychiatric or psychological symptomatology defined as above cut-off on Montgomery Åsberg Depression Ratings Scale, above clinical cut-off on hospital anxiety and depression scale (equal to or above 8)
- Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test, and/or clinical judgment
- Recent (< 4 weeks) intake of proton pump inhibitors, (e.g., omeprazole)
- Epilepsy
- Cerebral bleeding or history of cerebral bleeding
- Pregnancy or breastfeeding (will be asked)
- Claustrophobia
- Smoking or using tobacco including snuff
- Dominant left-hand
- Medical implant (e.g., pacemaker)
- Aneurysm clips in the head
- Shunts in the head
- Grenade-splinter or metal-splinter in the body (e.g., eyes)
- Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
- Comprehensive tooth-implants or prothesis
- Operated in the head
- Operated in the heart
- Swallowed a video-capsule
- Non-corrected astigmatism
- Intake of anti-inflammatory medication (including non-steroidal antiinflammatory drugs)
- Visual defect without possibility to use lenses during functional magnetic resonance imaging scanning
- Any other reason the investigator feels the subject is not suitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Örebro University, Region Örebro County
Örebro, Örebro County, 70182
About this study
Official title: Effect of Serotonergic Stimulation on the Gut-brain Axis in Irritable Bowel Syndrome Patients Compared With Healthy Subjects
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.
Read the 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.
- Conditions
- Healthy, Irritable Bowel Syndrome
- Being tested
- serotonergic stimulation, no serotonergic stimulation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serotonergic stimulationOther
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.
no serotonergic stimulationOther
Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.
| Study group | Role | What they receive |
|---|---|---|
| stimulated serotonergic activity | Experimental | Not described Receives: Other: serotonergic stimulation |
| unstimulated serotonergic activity | Experimental | Not described Receives: Other: no serotonergic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in functional brain response pattern to the barostat in stimulated compared to unstimulated serotonergic activity
functional magnetic resonance imaging
Measured: 1 week
Secondary outcomes (5)
Differences in functional brain response pattern to the Montreal Imaging Stress Task between stimulated and unstimulated serotonergic activity
functional magnetic resonance imaging
Measured: 1 week
Differences in functional brain response pattern to the Emotional Attention Task between stimulated and unstimulated serotonergic activity
functional magnetic resonance imaging
Measured: 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
Measured: 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
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start24 Apr 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County
- Responsible party
- Sponsor
- Investigators
- Robert Brummer, Prof., Principal investigator, Örebro University, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920410
- Sponsor's protocol ID
- 5HT
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2019
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Serotonergic Stimulation on the Gut-brain Axis in Irritable Bowel Syndrome Patients Compared With Healthy Subjects
- ClinicalTrials.gov ID
- NCT03920410
- Acronym / sponsor ID
- 5HT
- Conditions
- Healthy, Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Region Örebro County
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulated serotonergic activity | Experimental | Other: serotonergic stimulation |
| unstimulated serotonergic activity | Experimental | Other: no serotonergic stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects fulfill Rome IV diagnostic criteria for irritable bowel syndrome and pain frequency for at least 1 day per week in the last 12 weeks
- Males or females aged 18-65 years
- Signed informed consent
- Males and females aged 18-65 years of age
- Signed informed consent
Key exclusion criteria (50 listed)
- Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (< 12 weeks), antibiotics (< 12 weeks)
- Concurrent or recent (< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics)
- Diagnosis of major psychiatric or somatic disease other than part of irritable bowel syndrome
- Suicidal tendencies according to Montgomery Åsberg Depression Ratings Scale and/or clinical judgment
- Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test, and/or clinical judgment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serotonergic stimulationIncrease of serotonergic activity by a single oral administration of 10 mg Escitalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), packed in a coloured hydroxypropylmethylcellulose capsule. | Other | stimulated serotonergic activity |
| no serotonergic stimulationOral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose. | Other | unstimulated serotonergic activity |
Primary outcome
Differences in functional brain response pattern to the barostat in stimulated compared to unstimulated serotonergic activity
Time frame: 1 week
functional magnetic resonance imaging
5 secondary outcomes
Differences in functional brain response pattern to the Montreal Imaging Stress Task between stimulated and unstimulated serotonergic activity
Time frame: 1 week
Differences in functional brain response pattern to the Emotional Attention Task between stimulated and unstimulated serotonergic activity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Brummer, Prof. principal investigator
Örebro University, Region Örebro County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serotonergic stimulation and no serotonergic stimulation in people with Healthy and Irritable Bowel Syndrome, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in functional brain response pattern to the barostat in stimulated compared to unstimulated serotonergic activity (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.