Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
60 participants
Study Classification
OBSERVATIONAL
Study Start Date
2012-07-31
Study Completion Date
2026-05-31
Brief Summary
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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.
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Detailed Description
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The gut produces approximately 95% of serotonin (5-hydroxytryptamine; 5-HT) found in the human body; where, it is a very important mucosal signaling molecule participating in gut motility, sensation, and secretion.The vast majority of the gut-derived 5-HT is produced by specialized epithelial cells of The GI tract, called enterochromaffin (EC) cells. EC cells produce 5-HT from dietary tryptophan, this process involves the rate limiting enzyme tryptophan hydroxylase (TPH) 1, once produced this 5-HT can be released into the gut lumen, surrounding tissue and can enter the blood circulation.5-HT mediates many gastrointestinal functions, including secretion and peristalsis, by acting on a diverse range of 5-HT receptors. Five of the seven known receptor families of 5-HT (5-HT1, 5-HT2, 5-HT3, 5-HT4 and 5-HT7) are expressed in the gut.
5-HT has been evaluated in IBD and in animal models of colitis. An increase in numbers of EC cells expressing 5-HT is observed in CD and UC patients and consumption of selective 5-HT reuptake inhibitors is associated with microscopic colitis. In the present study, we plan to investigate the key elements of mucosal 5-HT signaling in CD patients for a better understanding of the role of 5-HT in pathogenesis of IBD.
5-HT has been evaluated in IBD and in animal models of colitis. An increase in numbers of EC cells expressing 5-HT is observed in CD and UC patients and consumption of selective 5-HT reuptake inhibitors is associated with microscopic colitis. In the present study, we plan to investigate the key elements of mucosal 5-HT signaling in CD patients for a better understanding of the role of 5-HT in pathogenesis of IBD.
Conditions
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Inflammatory Bowel Disease
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Healthy controls
Healthy control group will include participants consenting prior to colorectal cancer screening.
No interventions assigned to this group
CD patient groups
The patient groups will include patients with clinical diagnosis of CD.
No interventions assigned to this group
UC patient group
The patient groups will include patients with clinical diagnosis of UC.
No interventions assigned to this group
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
19 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Waliul I Khan, MBBS, PhD.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Pathology & Molecular Medicine, McMaster University, Hamilton, Canada.
John Marshall, MD, MSc, FRCPC, AGAF.
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, McMaster University, Hamilton, Canada.
Locations
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McMaster University Medical Center
Hamilton, Ontario, Canada
Site Status
RECRUITING
Countries
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Canada
Central Contacts
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References
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Coates MD, Mahoney CR, Linden DR, Sampson JE, Chen J, Blaszyk H, Crowell MD, Sharkey KA, Gershon MD, Mawe GM, Moses PL. Molecular defects in mucosal serotonin content and decreased serotonin reuptake transporter in ulcerative colitis and irritable bowel syndrome. Gastroenterology. 2004 Jun;126(7):1657-64. doi: 10.1053/j.gastro.2004.03.013.
Reference Type
BACKGROUND
Minderhoud IM, Oldenburg B, Schipper ME, ter Linde JJ, Samsom M. Serotonin synthesis and uptake in symptomatic patients with Crohn's disease in remission. Clin Gastroenterol Hepatol. 2007 Jun;5(6):714-20. doi: 10.1016/j.cgh.2007.02.013. Epub 2007 May 4.
Reference Type
BACKGROUND
El-Salhy M, Danielsson A, Stenling R, Grimelius L. Colonic endocrine cells in inflammatory bowel disease. J Intern Med. 1997 Nov;242(5):413-9. doi: 10.1046/j.1365-2796.1997.00237.x.
Reference Type
BACKGROUND
Sharkey KA, Mawe GM. Neuroimmune and epithelial interactions in intestinal inflammation. Curr Opin Pharmacol. 2002 Dec;2(6):669-77. doi: 10.1016/s1471-4892(02)00215-1.
Reference Type
BACKGROUND
Khan WI, Ghia JE. Gut hormones: emerging role in immune activation and inflammation. Clin Exp Immunol. 2010 Jul 1;161(1):19-27. doi: 10.1111/j.1365-2249.2010.04150.x. Epub 2010 Apr 9.
Reference Type
BACKGROUND
Buchan AM. Nutrient Tasting and Signaling Mechanisms in the Gut III. Endocrine cell recognition of luminal nutrients. Am J Physiol. 1999 Dec;277(6):G1103-7. doi: 10.1152/ajpgi.1999.277.6.G1103.
Reference Type
BACKGROUND
Rindi G, Kloppel G. Endocrine tumors of the gut and pancreas tumor biology and classification. Neuroendocrinology. 2004;80 Suppl 1:12-5. doi: 10.1159/000080733.
Reference Type
BACKGROUND
Gordon JI, Schmidt GH, Roth KA. Studies of intestinal stem cells using normal, chimeric, and transgenic mice. FASEB J. 1992 Sep;6(12):3039-50. doi: 10.1096/fasebj.6.12.1521737.
Reference Type
BACKGROUND
Lomax AE, Linden DR, Mawe GM, Sharkey KA. Effects of gastrointestinal inflammation on enteroendocrine cells and enteric neural reflex circuits. Auton Neurosci. 2006 Jun 30;126-127:250-7. doi: 10.1016/j.autneu.2006.02.015. Epub 2006 Apr 17.
Reference Type
BACKGROUND
Nagata K, Fujimiya M, Sugiura H, Uehara M. Intracellular localization of serotonin in mast cells of the colon in normal and colitis rats. Histochem J. 2001 Sep-Oct;33(9-10):559-68. doi: 10.1023/a:1014960026247.
Reference Type
BACKGROUND
Bertrand PP, Bertrand RL. Serotonin release and uptake in the gastrointestinal tract. Auton Neurosci. 2010 Feb 16;153(1-2):47-57. doi: 10.1016/j.autneu.2009.08.002. Epub 2009 Sep 2.
Reference Type
BACKGROUND
Spiller R. Serotonin and GI clinical disorders. Neuropharmacology. 2008 Nov;55(6):1072-80. doi: 10.1016/j.neuropharm.2008.07.016. Epub 2008 Jul 19.
Reference Type
BACKGROUND
Belai A, Boulos PB, Robson T, Burnstock G. Neurochemical coding in the small intestine of patients with Crohn's disease. Gut. 1997 Jun;40(6):767-74. doi: 10.1136/gut.40.6.767.
Reference Type
BACKGROUND
Wheatcroft J, Wakelin D, Smith A, Mahoney CR, Mawe G, Spiller R. Enterochromaffin cell hyperplasia and decreased serotonin transporter in a mouse model of postinfectious bowel dysfunction. Neurogastroenterol Motil. 2005 Dec;17(6):863-70. doi: 10.1111/j.1365-2982.2005.00719.x.
Reference Type
BACKGROUND
Gershon MD. Serotonin and its implication for the management of irritable bowel syndrome. Rev Gastroenterol Disord. 2003;3 Suppl 2:S25-34.
Reference Type
BACKGROUND
Kim DY, Camilleri M. Serotonin: a mediator of the brain-gut connection. Am J Gastroenterol. 2000 Oct;95(10):2698-709. doi: 10.1111/j.1572-0241.2000.03177.x. No abstract available.
Reference Type
BACKGROUND
Oshima S, Fujimura M, Fukimiya M. Changes in number of serotonin-containing cells and serotonin levels in the intestinal mucosa of rats with colitis induced by dextran sodium sulfate. Histochem Cell Biol. 1999 Oct;112(4):257-63. doi: 10.1007/s004180050445.
Reference Type
BACKGROUND
Linden DR, Chen JX, Gershon MD, Sharkey KA, Mawe GM. Serotonin availability is increased in mucosa of guinea pigs with TNBS-induced colitis. Am J Physiol Gastrointest Liver Physiol. 2003 Jul;285(1):G207-16. doi: 10.1152/ajpgi.00488.2002. Epub 2003 Mar 19.
Reference Type
BACKGROUND
Yang GB, Lackner AA. Proximity between 5-HT secreting enteroendocrine cells and lymphocytes in the gut mucosa of rhesus macaques (Macaca mulatta) is suggestive of a role for enterochromaffin cell 5-HT in mucosal immunity. J Neuroimmunol. 2004 Jan;146(1-2):46-9. doi: 10.1016/j.jneuroim.2003.10.044.
Reference Type
BACKGROUND
Wang H, Steeds J, Motomura Y, Deng Y, Verma-Gandhu M, El-Sharkawy RT, McLaughlin JT, Grencis RK, Khan WI. CD4+ T cell-mediated immunological control of enterochromaffin cell hyperplasia and 5-hydroxytryptamine production in enteric infection. Gut. 2007 Jul;56(7):949-57. doi: 10.1136/gut.2006.103226. Epub 2007 Feb 15.
Reference Type
BACKGROUND
Spiller R. Serotonin, inflammation, and IBS: fitting the jigsaw together? J Pediatr Gastroenterol Nutr. 2007 Dec;45 Suppl 2:S115-9. doi: 10.1097/MPG.0b013e31812e66da.
Reference Type
BACKGROUND
Gershon MD, Tack J. The serotonin signaling system: from basic understanding to drug development for functional GI disorders. Gastroenterology. 2007 Jan;132(1):397-414. doi: 10.1053/j.gastro.2006.11.002.
Reference Type
BACKGROUND
Idzko M, Panther E, Stratz C, Muller T, Bayer H, Zissel G, Durk T, Sorichter S, Di Virgilio F, Geissler M, Fiebich B, Herouy Y, Elsner P, Norgauer J, Ferrari D. The serotoninergic receptors of human dendritic cells: identification and coupling to cytokine release. J Immunol. 2004 May 15;172(10):6011-9. doi: 10.4049/jimmunol.172.10.6011.
Reference Type
BACKGROUND
Leon-Ponte M, Ahern GP, O'Connell PJ. Serotonin provides an accessory signal to enhance T-cell activation by signaling through the 5-HT7 receptor. Blood. 2007 Apr 15;109(8):3139-46. doi: 10.1182/blood-2006-10-052787. Epub 2006 Dec 7.
Reference Type
BACKGROUND
Meredith EJ, Chamba A, Holder MJ, Barnes NM, Gordon J. Close encounters of the monoamine kind: immune cells betray their nervous disposition. Immunology. 2005 Jul;115(3):289-95. doi: 10.1111/j.1365-2567.2005.02166.x.
Reference Type
BACKGROUND
Young MR, Matthews JP. Serotonin regulation of T-cell subpopulations and of macrophage accessory function. Immunology. 1995 Jan;84(1):148-52.
Reference Type
BACKGROUND
Ghia JE, Li N, Wang H, Collins M, Deng Y, El-Sharkawy RT, Cote F, Mallet J, Khan WI. Serotonin has a key role in pathogenesis of experimental colitis. Gastroenterology. 2009 Nov;137(5):1649-60. doi: 10.1053/j.gastro.2009.08.041. Epub 2009 Aug 23.
Reference Type
BACKGROUND
Wirtz S, Neufert C, Weigmann B, Neurath MF. Chemically induced mouse models of intestinal inflammation. Nat Protoc. 2007;2(3):541-6. doi: 10.1038/nprot.2007.41.
Reference Type
BACKGROUND
Costedio MM, Hyman N, Mawe GM. Serotonin and its role in colonic function and in gastrointestinal disorders. Dis Colon Rectum. 2007 Mar;50(3):376-88. doi: 10.1007/s10350-006-0763-3.
Reference Type
BACKGROUND
Heller F, Florian P, Bojarski C, Richter J, Christ M, Hillenbrand B, Mankertz J, Gitter AH, Burgel N, Fromm M, Zeitz M, Fuss I, Strober W, Schulzke JD. Interleukin-13 is the key effector Th2 cytokine in ulcerative colitis that affects epithelial tight junctions, apoptosis, and cell restitution. Gastroenterology. 2005 Aug;129(2):550-64. doi: 10.1016/j.gastro.2005.05.002.
Reference Type
BACKGROUND
Kidd M, Gustafsson BI, Drozdov I, Modlin IM. IL1beta- and LPS-induced serotonin secretion is increased in EC cells derived from Crohn's disease. Neurogastroenterol Motil. 2009 Apr;21(4):439-50. doi: 10.1111/j.1365-2982.2008.01210.x. Epub 2008 Oct 25.
Reference Type
BACKGROUND
Bishop AE, Pietroletti R, Taat CW, Brummelkamp WH, Polak JM. Increased populations of endocrine cells in Crohn's ileitis. Virchows Arch A Pathol Anat Histopathol. 1987;410(5):391-6. doi: 10.1007/BF00712758.
Reference Type
BACKGROUND
Khan WI, Motomura Y, Wang H, El-Sharkawy RT, Verdu EF, Verma-Gandhu M, Rollins BJ, Collins SM. Critical role of MCP-1 in the pathogenesis of experimental colitis in the context of immune and enterochromaffin cells. Am J Physiol Gastrointest Liver Physiol. 2006 Nov;291(5):G803-11. doi: 10.1152/ajpgi.00069.2006. Epub 2006 May 25.
Reference Type
BACKGROUND
Nakajima M, Shiihara Y, Shiba Y, Sano I, Sakai T, Mizumoto A, Itoh Z. Effect of 5-hydroxytryptamine on gastrointestinal motility in conscious guinea-pigs. Neurogastroenterol Motil. 1997 Dec;9(4):205-14. doi: 10.1046/j.1365-2982.1997.d01-56.x.
Reference Type
BACKGROUND
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. doi: 10.1016/j.ajpath.2010.10.028.
Reference Type
BACKGROUND
Magro F, Vieira-Coelho MA, Fraga S, Serrao MP, Veloso FT, Ribeiro T, Soares-da-Silva P. Impaired synthesis or cellular storage of norepinephrine, dopamine, and 5-hydroxytryptamine in human inflammatory bowel disease. Dig Dis Sci. 2002 Jan;47(1):216-24. doi: 10.1023/a:1013256629600.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
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12-239
Identifier Type: -
Identifier Source: org_study_id
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