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Investigating Serotonin Signalling in IBD Patients (IBD)

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. Identifier: NCT01650311
Recruitment Status : Recruiting
First Posted : July 26, 2012
Last Update Posted : September 2, 2020
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Alterations in normal serotonin (5-hydroxytryptamine;5-HT) signaling have been reported in ulcerative colitis (UC) and Crohn's disease (CD). Studies report an increase in enterochromaffin (EC) cell, main source of 5-HT in the gut, numbers in CD and UC patients. Up-regulated expression of mucosal Tryptophan hydroxylase (TPH)-1, catalytic enzyme in 5-HT production, messenger RNA (mRNA) have been found in CD patients in remission who are suffering the irritable bowel syndrome (IBS)-like symptoms. Alterations in normal 5-HT signaling has also been reported in animal models of inflammatory bowel disease (IBD). Thus, the aim of the proposed research project will be to study the alterations in 5-HT signalling accompanying GI inflammatory conditions, such as IBD.

Condition or disease
Inflammatory Bowel Disease

Detailed Description:

The gut produces approximately 95% of serotonin (5-hydroxytryptamine; 5-HT) found in the human body; where, it is a very important mucosal signaling molecule participating in gut motility, sensation, and secretion.The vast majority of the gut-derived 5-HT is produced by specialized epithelial cells of The GI tract, called enterochromaffin (EC) cells. EC cells produce 5-HT from dietary tryptophan, this process involves the rate limiting enzyme tryptophan hydroxylase (TPH) 1, once produced this 5-HT can be released into the gut lumen, surrounding tissue and can enter the blood circulation.5-HT mediates many gastrointestinal functions, including secretion and peristalsis, by acting on a diverse range of 5-HT receptors. Five of the seven known receptor families of 5-HT (5-HT1, 5-HT2, 5-HT3, 5-HT4 and 5-HT7) are expressed in the gut.

5-HT has been evaluated in IBD and in animal models of colitis. An increase in numbers of EC cells expressing 5-HT is observed in CD and UC patients and consumption of selective 5-HT reuptake inhibitors is associated with microscopic colitis. In the present study, we plan to investigate the key elements of mucosal 5-HT signaling in CD patients for a better understanding of the role of 5-HT in pathogenesis of IBD.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Serotonin Signalling in IBD Patients
Study Start Date : July 2012
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Healthy controls
Healthy control group will include participants consenting prior to colorectal cancer screening.
CD patient groups
The patient groups will include patients with clinical diagnosis of CD.
UC patient group
The patient groups will include patients with clinical diagnosis of UC.

Primary Outcome Measures :
  1. TPH1 and SERT expression [ Time Frame: At the time of sample collection ]

Secondary Outcome Measures :
  1. Receptor expressions [ Time Frame: At the time of sample collection ]

Biospecimen Retention:   Samples With DNA
Samples will be collected from inflamed and non-inflamed regions, spanning the distal colon to distal ileum.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All potential participants will be included only if they meet the stringent inclusion criteria in place. Only when their eligibility is confirmed the potential participants will be approached for consent prior to endoscopy. For healthy subjects, they will be screened and consented from the colorectal screening list, also prior to endoscopy.

Inclusion Criteria:

  • Patient groups: Disease diagnosis (CD or UC),duration of disease, previous/type of treatments, duration of treatment and disease prognosis.
  • Healthy controls: No diagnosis of CD or UC and no diagnosis of IBS.

Exclusion Criteria:

  • Patient groups: Drugs that directly affect components of 5-HT signaling, any other disease or condition that may interfere with study assessments as judged by the investigator.
  • Healthy controls:Chronic use of any anti-inflammatory drugs, drugs that directly affect components of 5-HT signalling and any other disease or condition that may interfere with study assessments as judged by the investigator.

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 identifier (NCT number): NCT01650311

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Contact: Md. Sharif Shajib, BSc. 905-525-9140 ext 22970
Contact: Janice Kim, PhD. 905-525-9140 ext 22970

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Canada, Ontario
McMaster University Medical Center Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
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Principal Investigator: Waliul I Khan, MBBS, PhD. Dept. of Pathology & Molecular Medicine, McMaster University, Hamilton, Canada.
Principal Investigator: John Marshall, MD, MSc, FRCPC, AGAF. Department of Medicine, McMaster University, Hamilton, Canada.

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Responsible Party: McMaster University Identifier: NCT01650311    
Other Study ID Numbers: 12-239
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by McMaster University:
IBD, CD, UC, Serotonin, 5-HT
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases