NCT01650311 Investigating Serotonin Signalling in IBD Patients
| NCT ID | NCT01650311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Inflammatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2012-07 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2012-07 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Waliul I Khan, MBBS, PhD.
PRINCIPAL INVESTIGATOR
Dept. of Pathology & Molecular Medicine, McMaster University, Hamilton, Canada.
Frequently Asked Questions
Who can join the NCT01650311 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 85 Years, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01650311 currently recruiting?
Yes, NCT01650311 is actively recruiting participants. Contact the research team at grondij@mcmaster.ca for enrollment information.
Where is the NCT01650311 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT01650311 clinical trial?
NCT01650311 is sponsored by McMaster University. The principal investigator is Waliul I Khan, MBBS, PhD. at Dept. of Pathology & Molecular Medicine, McMaster University, Hamilton, Canada.. The trial plans to enroll 60 participants.