| 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.
|
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- Li N, Ghia JE, Wang H, McClemens J, Cote F, Suehiro Y, Mallet J, Khan WI. Serotonin activates dendritic cell function in the context of gut inflammation. Am J Pathol. 2011 Feb;178(2):662-71.
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- Wong JM, Wei SC. Efficacy of Pentasa tablets for the treatment of inflammatory bowel disease. J Formos Med Assoc. 2003 Sep;102(9):613-9.
- Cremon C, Carini G, Wang B, Vasina V, Cogliandro RF, De Giorgio R, Stanghellini V, Grundy D, Tonini M, De Ponti F, Corinaldesi R, Barbara G. Intestinal serotonin release, sensory neuron activation, and abdominal pain in irritable bowel syndrome. Am J Gastroenterol. 2011 Jul;106(7):1290-8. doi: 10.1038/ajg.2011.86. Epub 2011 Mar 22.
|
| |
| 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 |
|
|
| 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 |