Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01650311

Investigating Serotonin Signalling in IBD Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University Medical Center

Hamilton, Ontario, L8S 4K1, Canada

Location status: Recruiting

About this study

The gut produces approximately 95% of serotonin (5-hydroxytryptamine; 5-HT) found in the human body; where, it is a very important mucosal signaling molecule participating in gut motility, sensation, and secretion.The vast majority of the gut-derived 5-HT is produced by specialized epithelial cells of The GI tract, called enterochromaffin (EC) cells. EC cells produce 5-HT from dietary tryptophan, this process involves the rate limiting enzyme tryptophan hydroxylase (TPH) 1, once produced this 5-HT can be released into the gut lumen, surrounding tissue and can enter the blood circulation.5-HT mediates many gastrointestinal functions, including secretion and peristalsis, by acting on a diverse range of 5-HT receptors. Five of the seven known receptor families of 5-HT (5-HT1, 5-HT2, 5-HT3, 5-HT4 and 5-HT7) are expressed in the gut.

5-HT has been evaluated in IBD and in animal models of colitis. An increase in numbers of EC cells expressing 5-HT is observed in CD and UC patients and consumption of selective 5-HT reuptake inhibitors is associated with microscopic colitis. In the present study, we plan to investigate the key elements of mucosal 5-HT signaling in CD patients for a better understanding of the role of 5-HT in pathogenesis of IBD.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. TPH1

    Time frame: 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.

Secondary outcomes

  1. Receptor expressions

    Time frame: At the time of sample collection

    Levels of the various serotonin receptors will be measured to assess changes in serotonin signaling

Study contacts

Contact information is provided by the study sponsor or research team.

Jensine Grondin, MSc.

CONTACT

[email protected]

905-525-9140 ext. 22970

Tyler Seto, BSc

CONTACT

[email protected]

905-525-9140 ext. 22970

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Acronym: IBD

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2012
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.