Study Results
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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RECRUITING
260 participants
OBSERVATIONAL
2012-10-01
2026-11-01
Brief Summary
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This will be complemented by a translational phase of human-mouse hybrid experiments in which germ-free mice will be colonized with feces from these patients with different GI disease and non-disease controls and we will compare symptoms, microbiota composition and histological changes in the gut and in the brain of the mice.
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Detailed Description
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General Objective The objective of this study is to identify different patterns of intestinal microbiota in patients diagnosed with inflammatory bowel disease, microscopic colitis, functional diarrhea, severe motility disorders, celiac disease and irritable bowel syndrome and to compare it with non-disease controls, by assessing data (questionnaires) and samples (stool, blood and tissue) from single time point (endoscopy/colonoscopy appointment).
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Chronic gastrointestinal disorders
A cohort of 260 patients (150 diagnosed with IBD, 40 with IBS, 30 with celiac disease, 10 with MC, 10 with functional diarrhea and 30 non-disease controls) of either sex between 18 and 75 years of age consulting to either the GI Clinical Investigation, the Endoscopy Unit (McMaster University)
Endoscopy/Colonoscopy
Esophagogastroduodenoscopy and colonoscopy with video recording and biopsy collection
Interventions
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Endoscopy/Colonoscopy
Esophagogastroduodenoscopy and colonoscopy with video recording and biopsy collection
Eligibility Criteria
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Inclusion Criteria
* Willingness to participate
* Signed Informed Consent
Exclusion Criteria
* Probiotics in the previous month
18 Years
75 Years
ALL
Yes
Sponsors
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McMaster University
OTHER
Responsible Party
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Locations
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McMaster University
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Bercik P. The microbiota-gut-brain axis: learning from intestinal bacteria? Gut. 2011 Mar;60(3):288-9. doi: 10.1136/gut.2010.226779. No abstract available.
Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
Parkes GC, Brostoff J, Whelan K, Sanderson JD. Gastrointestinal microbiota in irritable bowel syndrome: their role in its pathogenesis and treatment. Am J Gastroenterol. 2008 Jun;103(6):1557-67. doi: 10.1111/j.1572-0241.2008.01869.x. Epub 2008 May 29.
Bolino CM, Bercik P. Pathogenic factors involved in the development of irritable bowel syndrome: focus on a microbial role. Infect Dis Clin North Am. 2010 Dec;24(4):961-75, ix. doi: 10.1016/j.idc.2010.07.005.
Collins SM, Denou E, Verdu EF, Bercik P. The putative role of the intestinal microbiota in the irritable bowel syndrome. Dig Liver Dis. 2009 Dec;41(12):850-3. doi: 10.1016/j.dld.2009.07.023. Epub 2009 Sep 8.
Gwee KA, Collins SM, Read NW, Rajnakova A, Deng Y, Graham JC, McKendrick MW, Moochhala SM. Increased rectal mucosal expression of interleukin 1beta in recently acquired post-infectious irritable bowel syndrome. Gut. 2003 Apr;52(4):523-6. doi: 10.1136/gut.52.4.523.
Gwee KA, Leong YL, Graham C, McKendrick MW, Collins SM, Walters SJ, Underwood JE, Read NW. The role of psychological and biological factors in postinfective gut dysfunction. Gut. 1999 Mar;44(3):400-6. doi: 10.1136/gut.44.3.400.
Dunlop SP, Jenkins D, Neal KR, Spiller RC. Relative importance of enterochromaffin cell hyperplasia, anxiety, and depression in postinfectious IBS. Gastroenterology. 2003 Dec;125(6):1651-9. doi: 10.1053/j.gastro.2003.09.028.
Marshall JK, Thabane M, Garg AX, Clark WF, Salvadori M, Collins SM; Walkerton Health Study Investigators. Incidence and epidemiology of irritable bowel syndrome after a large waterborne outbreak of bacterial dysentery. Gastroenterology. 2006 Aug;131(2):445-50; quiz 660. doi: 10.1053/j.gastro.2006.05.053.
Malinen E, Rinttila T, Kajander K, Matto J, Kassinen A, Krogius L, Saarela M, Korpela R, Palva A. Analysis of the fecal microbiota of irritable bowel syndrome patients and healthy controls with real-time PCR. Am J Gastroenterol. 2005 Feb;100(2):373-82. doi: 10.1111/j.1572-0241.2005.40312.x.
Kerckhoffs AP, Samsom M, van der Rest ME, de Vogel J, Knol J, Ben-Amor K, Akkermans LM. Lower Bifidobacteria counts in both duodenal mucosa-associated and fecal microbiota in irritable bowel syndrome patients. World J Gastroenterol. 2009 Jun 21;15(23):2887-92. doi: 10.3748/wjg.15.2887.
Krogius-Kurikka L, Lyra A, Malinen E, Aarnikunnas J, Tuimala J, Paulin L, Makivuokko H, Kajander K, Palva A. Microbial community analysis reveals high level phylogenetic alterations in the overall gastrointestinal microbiota of diarrhoea-predominant irritable bowel syndrome sufferers. BMC Gastroenterol. 2009 Dec 17;9:95. doi: 10.1186/1471-230X-9-95.
Carroll IM, Chang YH, Park J, Sartor RB, Ringel Y. Luminal and mucosal-associated intestinal microbiota in patients with diarrhea-predominant irritable bowel syndrome. Gut Pathog. 2010 Dec 9;2(1):19. doi: 10.1186/1757-4749-2-19.
Tana C, Umesaki Y, Imaoka A, Handa T, Kanazawa M, Fukudo S. Altered profiles of intestinal microbiota and organic acids may be the origin of symptoms in irritable bowel syndrome. Neurogastroenterol Motil. 2010 May;22(5):512-9, e114-5. doi: 10.1111/j.1365-2982.2009.01427.x. Epub 2009 Nov 10.
Nistal E, Caminero A, Vivas S, Ruiz de Morales JM, Saenz de Miera LE, Rodriguez-Aparicio LB, Casqueiro J. Differences in faecal bacteria populations and faecal bacteria metabolism in healthy adults and celiac disease patients. Biochimie. 2012 Aug;94(8):1724-9. doi: 10.1016/j.biochi.2012.03.025. Epub 2012 Apr 20.
Nadal I, Donant E, Ribes-Koninckx C, Calabuig M, Sanz Y. Imbalance in the composition of the duodenal microbiota of children with coeliac disease. J Med Microbiol. 2007 Dec;56(Pt 12):1669-1674. doi: 10.1099/jmm.0.47410-0.
Collado MC, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y. Imbalances in faecal and duodenal Bifidobacterium species composition in active and non-active coeliac disease. BMC Microbiol. 2008 Dec 22;8:232. doi: 10.1186/1471-2180-8-232.
Collado MC, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y. Specific duodenal and faecal bacterial groups associated with paediatric coeliac disease. J Clin Pathol. 2009 Mar;62(3):264-9. doi: 10.1136/jcp.2008.061366. Epub 2008 Nov 7.
Sanchez E, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y. Intestinal Bacteroides species associated with coeliac disease. J Clin Pathol. 2010 Dec;63(12):1105-11. doi: 10.1136/jcp.2010.076950. Epub 2010 Oct 23.
Gillevet P, Sikaroodi M, Keshavarzian A, Mutlu EA. Quantitative assessment of the human gut microbiome using multitag pyrosequencing. Chem Biodivers. 2010 May;7(5):1065-75. doi: 10.1002/cbdv.200900322.
Other Identifiers
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HiREB-15311
Identifier Type: -
Identifier Source: org_study_id
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