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Investigating Serotonin Signalling in IBD Patients (IBD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01650311
First received: June 17, 2012
Last updated: March 22, 2017
Last verified: March 2017

June 17, 2012
March 22, 2017
July 2012
May 2018   (Final data collection date for primary outcome measure)
TPH1 and SERT expression [ Time Frame: At the time of sample collection ]
Colonic 5-HT levels [ Time Frame: At the time of tissue collection ]
Complete list of historical versions of study NCT01650311 on ClinicalTrials.gov Archive Site
Receptor expressions [ Time Frame: At the time of sample collection ]
  • Receptor expressions [ Time Frame: At the time of tissue collection ]
  • Colonic cytokine levels [ Time Frame: At the time of tissue collection ]
Not Provided
Not Provided
 
Investigating Serotonin Signalling in IBD Patients
Investigating Serotonin Signalling in IBD Patients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Samples will be collected from inflamed and non-inflamed regions, spanning the distal colon to distal ileum.
Non-Probability Sample
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.
Inflammatory Bowel Disease
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
May 2018
May 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01650311
12-239
No
Not Provided
No
Not Provided
McMaster University
McMaster University
Not Provided
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.
McMaster University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP