Overview

This trial is active, not recruiting.

Condition inflammatory bowel disease
Sponsor McMaster University
Start date July 2012
End date May 2016
Trial size 60 participants
Trial identifier NCT01650311, 12-239

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Healthy control group will include participants consenting prior to colorectal cancer screening.
The patient groups will include patients with clinical diagnosis of CD.
The patient groups will include patients with clinical diagnosis of UC.

Primary Outcomes

Measure
Colonic 5-HT levels
time frame: At the time of tissue collection

Secondary Outcomes

Measure
Receptor expressions
time frame: At the time of tissue collection
Colonic cytokine levels
time frame: At the time of tissue collection

Eligibility Criteria

Male or female participants from 19 years up to 85 years old.

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.

Additional Information

Official title Investigating Serotonin Signalling in IBD Patients
Principal investigator Waliul I Khan, MBBS, PhD.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by McMaster University.