Recruiting

Serotonin Signaling

Sponsor:

McMaster University

Code:

NCT01650311

Conditions

Inflammatory Bowel Disease

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Inflammatory Bowel Disease

Study ID

NCT01650311

Start date

Jul, 2012

Status verified date

Oct, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy controls

Healthy control group will include participants consenting prior to colorectal cancer screening.

CD patient groups

The patient groups will include patients with clinical diagnosis of CD.

UC patient group

The patient groups will include patients with clinical diagnosis of UC.

Primary outcome measure

  • TPH1 [ Time Frame: At the time of sample collection ]

Central Contacts and Locations

Central contacts

Jensine Grondin, MSc.

905-525-9140grondij@mcmaster.ca

Tyler Seto, BSc

905-525-9140setot2@mcmaster.ca

Locations

McMaster University Medical Center

Recruiting

Hamilton, Ontario, Canada, L8S 4K1

More Information

Sponsor

McMaster University

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • IBD, CD, UC, Serotonin, 5-HT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.