Investigating Serotonin Signalling in IBD Patients

NCT01650311 | Recruiting

• 1 other identifier: 12-239
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

IBD, CD, UC, Serotonin, 5-HT

Outcome Measures

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.

  At the time of sample collection

Secondary Outcomes (1)

• Receptor expressions

  At the time of sample collection

Study Arms (3)

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.

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8S 4K1, Canada

RECRUITING

Related Publications (38)

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Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected from inflamed and non-inflamed regions, spanning the distal colon to distal ileum.

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Waliul I Khan, MBBS, PhD.

  Dept. of Pathology & Molecular Medicine, McMaster University, Hamilton, Canada.

  PRINCIPAL INVESTIGATOR

• John Marshall, MD, MSc, FRCPC, AGAF.

  Department of Medicine, McMaster University, Hamilton, Canada.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jensine Grondin, MSc.

CONTACT

905-525-9140; grondij@mcmaster.ca

Tyler Seto, BSc

CONTACT

905-525-9140; setot2@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)