Effect of Serotonergic Stimulation on the Gut-brain Axis

NCT ID: NCT03920410

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

stimulated serotonergic activity

Group Type EXPERIMENTAL

serotonergic stimulation

Intervention Type 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.

unstimulated serotonergic activity

Group Type EXPERIMENTAL

no serotonergic stimulation

Intervention Type OTHER

Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

serotonergic stimulation

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.

Intervention Type OTHER

no serotonergic stimulation

Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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
2. Males or females aged 18-65 years
3. Signed informed consent


1. Males and females aged 18-65 years of age
2. Signed informed consent

Exclusion Criteria

1. Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (\< 12 weeks), antibiotics (\< 12 weeks)
2. 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)
3. Diagnosis of major psychiatric or somatic disease other than part of irritable bowel syndrome
4. Suicidal tendencies according to Montgomery Åsberg Depression Ratings Scale and/or clinical judgment
5. Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test, and/or clinical judgment
6. Recent (\< 4 weeks) intake of proton pump inhibitors (e.g., omeprazole)
7. Epilepsy
8. Cerebral bleeding or history of cerebral bleeding
9. Pregnancy or breastfeeding (will be asked)
10. Claustrophobia
11. Smoking or using tobacco including snuff
12. Dominant left-hand
13. Medical implant (e.g., pacemaker)
14. Aneurysm clips in the head
15. Shunts in the head
16. Grenade-splinter or metal-splinter in the body (e.g., eyes)
17. Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
18. Comprehensive tooth-implants or prothesis
19. Operated in the head
20. Operated in the heart
21. Swallowed a video-capsule
22. Non-corrected astigmatism
23. Regular intake of antiinflammatory medication (including non-steroidal antiinflammatory drugs)
24. Visual defect without possibility to use lenses during functional magnetic resonance imaging scanning
25. Any other reason the investigator feels the subject is not suitable for participation in the study


1. Concurrent or recent history of gastrointestinal disorders or any somatic disorder
2. Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (\< 12 weeks), antibiotics (\< 12 weeks)
3. 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)
4. 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)
5. Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test, and/or clinical judgment
6. Recent (\< 4 weeks) intake of proton pump inhibitors, (e.g., omeprazole)
7. Epilepsy
8. Cerebral bleeding or history of cerebral bleeding
9. Pregnancy or breastfeeding (will be asked)
10. Claustrophobia
11. Smoking or using tobacco including snuff
12. Dominant left-hand
13. Medical implant (e.g., pacemaker)
14. Aneurysm clips in the head
15. Shunts in the head
16. Grenade-splinter or metal-splinter in the body (e.g., eyes)
17. Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
18. Comprehensive tooth-implants or prothesis
19. Operated in the head
20. Operated in the heart
21. Swallowed a video-capsule
22. Non-corrected astigmatism
23. Intake of anti-inflammatory medication (including non-steroidal antiinflammatory drugs)
24. Visual defect without possibility to use lenses during functional magnetic resonance imaging scanning
25. Any other reason the investigator feels the subject is not suitable for participation in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Örebro County

OTHER

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Brummer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Region Örebro County

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Örebro University, Region Örebro County

Örebro, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5HT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cerebral Cortical Influences on Autonomic Function
NCT03869372 ACTIVE_NOT_RECRUITING NA
Microbiota Profiling in IBS
NCT03720314 COMPLETED
Early Signs of Parkinsons Disease in IBS
NCT05573542 ENROLLING_BY_INVITATION