Investigating Serotonin Signalling in IBD Patients (IBD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01650311
First received: June 17, 2012
Last updated: April 1, 2016
Last verified: April 2016
  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 2016
Estimated Primary Completion Date: May 2016 (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

Locations
Canada, Ontario
McMaster University Medical Center
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: April 1, 2016
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 25, 2016