Gut Microbiota in Chronic GI Diseases

NCT06532110 | Recruiting

• 1 other identifier: HiREB-15311
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The study involves characterizing the microbiota of patients with IBS, functional diarrhea, IBD, severe motility disorders and celiac disease. 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.

Conditions

Microbiota

Keywords

microbiota; chronic gastrointestinal disorders; colonization; metabolites

Outcome Measures

Primary Outcomes (1)

• To identify different patterns of intestinal microbiota in patients diagnosed with chronic gastrointestinal disorders or controls

  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.

  October 2013 - October 2026

Secondary Outcomes (3)

• To study the effect of microbiota on the immune system

  October 2013 - October 2026

• To compare luminal microbiota composition vs. mucosa-associated microbiota composition in patients diagnosed with IBD, IBS, microscopic colitis, functional diarrhea, severe motility disorders and celiac disease and non-disease controls.

  October 2013 - October 2026

• To assess and compare the metabolic activity of gut bacteria of IBD, IBS, microscopic colitis, severe motility disorders, functional diarrhea and celiac disease patients and non-disease controls

  October 2013 - October 2026

Study Arms (1)

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)

Other: Endoscopy/Colonoscopy

Interventions

Endoscopy/Colonoscopy OTHER

Esophagogastroduodenoscopy and colonoscopy with video recording and biopsy collection

Chronic gastrointestinal disorders

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of 260 patients of either sex between 18 and 75 years of age consulting to either the GI Clinical Investigation, the Endoscopy Unit (McMaster University Endoscopy Centre)

You may qualify if:

• Diagnosis of IBD, active celiac disease (aTTG positive + endoscopic view and histological findings compatible), IBS (Rome IV criteria or physician diagnosis) severe motility disorders (severe constipation, severe functional dyspepsia) gluten sensitivity (IBS diarrhea predominant with positive anti gliadin antibodies and negative aTTG), functional diarrhea (Rome IV criteria), anal fissure and/or fistula or non-disease control individual or 1st degree family member of celiac patient.
• Willingness to participate
• Signed Informed Consent

You may not qualify if:

• Antibiotics in the last month
• Probiotics in the previous month

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

Related Publications (20)

• 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.

  PMID: 21296788 RESULT

• 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.

  PMID: 22730468 RESULT

• 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.

  PMID: 18513268 RESULT

• 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.

  PMID: 20937460 RESULT

• 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.

  PMID: 19740713 RESULT

• 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.

  PMID: 12631663 RESULT

• 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.

  PMID: 10026328 RESULT

• 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.

  PMID: 14724817 RESULT

• 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.

  PMID: 16890598 RESULT

• 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.

  PMID: 15667495 RESULT

• 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.

  PMID: 19533811 RESULT

• 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.

  PMID: 20015409 RESULT

• 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.

  PMID: 21143915 RESULT

• 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.

  PMID: 19903265 RESULT

• 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.

  PMID: 22542995 RESULT

• 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.

  PMID: 18033837 RESULT

• 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.

  PMID: 19102766 RESULT

• 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.

  PMID: 18996905 RESULT

• 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.

  PMID: 20972239 RESULT

• 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.

  PMID: 20491064 RESULT

MeSH Terms

Interventions

Endoscopy; Colonoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Central Study Contacts

Premysl Bercik, MD

CONTACT

905 521 2100; bercikp@mcmaster.ca

Gaston Rueda, MD

CONTACT

9055212100; ruedag@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: October 1, 2012
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)