Investigating Serotonin Signalling in IBD Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01650311
First received: June 17, 2012
Last updated: January 21, 2013
Last verified: January 2013

June 17, 2012
January 21, 2013
July 2012
May 2013   (final data collection date for primary outcome measure)
Colonic 5-HT levels [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01650311 on ClinicalTrials.gov Archive Site
  • Receptor expressions [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]
  • Colonic cytokine levels [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Investigating Serotonin Signalling in IBD Patients
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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.

Inflammatory Bowel Disease
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years to 85 Years
Yes
Contact: Zack Muqtadir, CCRA 905-525-9140 ext 21955 muqtadz@mcmaster.ca
Contact: Md. Sharif Shajib, BSc. 905-525-9140 ext 22970 shajib.m.s@mcmaster.ca
Canada
 
NCT01650311
12-239
No
McMaster University
McMaster University
Not Provided
Principal Investigator: 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.
McMaster University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP