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Effect of Serotonergic Stimulation on the Gut-brain Axis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920410
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Region Örebro County
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Irritable Bowel Syndrome Other: serotonergic stimulation Other: no serotonergic stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Serotonergic Stimulation on the Gut-brain Axis in Irritable Bowel Syndrome Patients Compared With Healthy Subjects
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: stimulated serotonergic activity Other: 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.

Experimental: unstimulated serotonergic activity Other: no serotonergic stimulation
Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.




Primary Outcome Measures :
  1. Differences in functional brain response pattern to the barostat in stimulated compared to unstimulated serotonergic activity [ Time Frame: 1 week ]
    functional magnetic resonance imaging


Secondary Outcome Measures :
  1. Differences in functional brain response pattern to the Montreal Imaging Stress Task between stimulated and unstimulated serotonergic activity [ Time Frame: 1 week ]
    functional magnetic resonance imaging

  2. Differences in functional brain response pattern to the Emotional Attention Task between stimulated and unstimulated serotonergic activity [ Time Frame: 1 week ]
    functional magnetic resonance imaging

  3. 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 ]
    functional magnetic resonance imaging

  4. 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 ]
    functional magnetic resonance imaging

  5. 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 ]
    functional magnetic resonance imaging



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for the irritable bowel syndrome group:

  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

Exclusion criteria for the irritable bowel syndrome group:

  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

Inclusion criteria for healthy group:

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

Exclusion criteria for the healthy group:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920410


Contacts
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Contact: Robert Brummer, Prof. 004619303731 robert.brummer@oru.se

Locations
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Sweden
Örebro University, Region Örebro County Recruiting
Örebro, Sweden, 70182
Contact: Robert Brummer, Prof.    004619303731    robert.brummer@oru.se   
Sponsors and Collaborators
Örebro University, Sweden
Region Örebro County
Investigators
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Principal Investigator: Robert Brummer, Prof. Örebro University, Region Örebro County
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Responsible Party: Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT03920410    
Other Study ID Numbers: 5HT
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases