Investigating Serotonin Signalling in IBD Patients
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Purpose
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 |
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Inflammatory Bowel Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Investigating Serotonin Signalling in IBD Patients |
- Colonic 5-HT levels [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]
- Receptor expressions [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]
- Colonic cytokine levels [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Samples will be collected from inflamed and non-inflamed regions, spanning the distal colon to distal ileum.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Healthy controls
Healthy control group will include participants consenting prior to colorectal cancer screening.
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CD patient groups
The patient groups will include patients with clinical diagnosis of CD.
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UC patient group
The patient groups will include patients with clinical diagnosis of UC.
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Eligibility| Ages Eligible for Study: | 19 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | 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.
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.
Contacts and Locations| Contact: Zack Muqtadir, CCRA | 905-525-9140 ext 21955 | muqtadz@mcmaster.ca |
| Contact: Md. Sharif Shajib, BSc. | 905-525-9140 ext 22970 | shajib.m.s@mcmaster.ca |
| Canada, Ontario | |
| McMaster University Medical Center | Recruiting |
| Hamilton, Ontario, Canada, L8S 4K1 | |
| 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. |
More Information
Publications:
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT01650311 History of Changes |
| Other Study ID Numbers: | 12-239 |
| Study First Received: | June 17, 2012 |
| Last Updated: | January 21, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McMaster University:
|
IBD, CD, UC, Serotonin, 5-HT |
Additional relevant MeSH terms:
|
Inflammatory Bowel Diseases Intestinal Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Serotonin |
Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013