Investigating serotonin signaling in patients with inflammatory bowel disease
Official title: Investigating Serotonin Signalling in IBD Patients
Run by McMaster University · NCT01650311 · Data updated 2026-11-12
This study looks at how changes in serotonin signaling might affect people with inflammatory bowel disease, like Crohn's disease and ulcerative colitis, to help find new ways to manage their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years to 85 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | July 2012 |
| Main results expected | November 2027 |
| Study ends | November 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT01650311 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study include patients diagnosed with Crohn's disease or ulcerative colitis, as well as healthy controls without these conditions.
✕Probably not a fit
Patients who are currently using drugs that directly affect serotonin signaling or have other conditions that may interfere with study assessments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the alterations in serotonin (5-HT) signaling in patients diagnosed with inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC). The research will focus on the role of enterochromaffin (EC) cells, which are responsible for producing the majority of gut-derived serotonin, and how changes in serotonin production and signaling may contribute to the pathogenesis of IBD. By examining the expression of tryptophan hydroxylase (TPH)-1 and the overall serotonin signaling pathway, the study seeks to enhance understanding of gastrointestinal functions affected in these conditions. The findings could provide insights into potential therapeutic targets for managing IBD symptoms.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and management of inflammatory bowel disease symptoms through targeted therapies related to serotonin signaling.
How similar studies have gone: While there have been studies evaluating serotonin in IBD, this specific investigation into the mucosal serotonin signaling in CD patients is novel and aims to provide new insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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McMaster University Medical Center
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Waliul I Khan, MBBS, PhD. — Dept. of Pathology & Molecular Medicine, McMaster University, Hamilton, Canada.
- Study coordinator: Jensine Grondin, MSc.
- Email: grondij@mcmaster.ca
- Phone: 905-525-9140
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.