Investigating Serotonin Signalling in IBD Patients
ConditionInflammatory Bowel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-85
SponsorMcMaster University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 3 trial groupsGroup A: Healthy controls
Group B: CD patient groups
Group C: UC patient group
Trial outcomes
Primary outcomes
1
TPH1
Levels of the gene expression and/or protein quantifications of the enzyme Tph1 will be measured to assess production of 5HT.
Time frame
At the time of sample collectionSecondary outcomes
1
Receptor expressions
Levels of the various serotonin receptors will be measured to assess changes in serotonin signaling
Time frame
At the time of sample collectionSponsors and contacts
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Source ClinicalTrials.gov