Investigating Serotonin Signalling in IBD Patients

NCT01650311 · tracked via the Priya Life Science Canada tracker

Sponsor

McMaster University

Phase

Observational

Started

2012-07

Last updated

2024-11-20

Condition(s) studied

Inflammatory Bowel Disease

Study 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

Sex

ALL

Min age

19 Years

Max age

85 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

TPH1 — At the time of sample collection
Levels of the gene expression and/or protein quantifications of the enzyme Tph1 will be measured to assess production of 5HT.

Trial sites (1)

Facility	City	Region	Status
McMaster University Medical Center	Hamilton	Ontario	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01650311 on ClinicalTrials.gov ↗ ← All trials in Canada