Effect of Serotonergic Stimulation on the Gut-brain Axis
NCT ID: NCT03920410
Last Updated: 2025-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
58 participants
INTERVENTIONAL
2019-04-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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stimulated serotonergic activity
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.
unstimulated serotonergic activity
no serotonergic stimulation
Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.
Interventions
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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.
no serotonergic stimulation
Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Region Örebro County
OTHER
Örebro University, Sweden
OTHER
Responsible Party
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Principal Investigators
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Robert Brummer, Prof.
Role: PRINCIPAL_INVESTIGATOR
Örebro University, Region Örebro County
Locations
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Örebro University, Region Örebro County
Örebro, , Sweden
Countries
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Other Identifiers
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5HT
Identifier Type: -
Identifier Source: org_study_id
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