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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
  Purpose

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.


Condition
Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Serotonin Signalling in IBD Patients

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Colonic 5-HT levels [ Time Frame: At the time of tissue collection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650311

Contacts
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

Locations
Canada, Ontario
McMaster University Medical Center Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Investigators
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.
  More Information

Publications:

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01650311     History of Changes
Other Study ID Numbers: 12-239
Study First Received: June 17, 2012
Last Updated: January 21, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
IBD, CD, UC, Serotonin, 5-HT

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Serotonin
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists

ClinicalTrials.gov processed this record on November 20, 2014