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Recruiting NCT06532110

Gut Microbiota in Chronic GI Diseases

— Observational Microbiota

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopy/Colonoscopy.
Who it may be relevant to
Registry conditions: Microbiota. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Role of Gut Microbiota in Chronic GI Diseases: A Pilot Study

Overview

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.

Detailed description

A complex community of microbes collectively referred to as microbiota, inhabit the human body. The intestinal microbiota is a diverse and dynamic ecosystem, which has developed a mutualistic relationship with its host and plays a crucial role in the development of the host's innate and adaptive immune responses. This ecosystem serves the host by protecting against pathogens, harvesting otherwise inaccessible nutrients, aiding in neutralization of drugs and carcinogens, and affecting the metabolism of lipids. Gut bacteria modulate intestinal motility, barrier function and visceral perception. A better understanding of the role of microbiota in the proposed GI diseases will have profound impact in the characterization of future biomarkers and has also potential treatment implications. As the microbiota may be disturbed in the mentioned GI conditions, a possible treatment approach could be to correct dysbiosis either by the administration of an antibiotic or a preparation of 'beneficial' bacteria (probiotics) according to each bacteria profile.

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).

Interventions

  • Other Endoscopy/Colonoscopy
    Esophagogastroduodenoscopy and colonoscopy with video recording and biopsy collection

Primary outcome measures

  • To identify different patterns of intestinal microbiota in patients diagnosed with chronic gastrointestinal disorders or controls [Time frame: October 2013 - October 2026]
Secondary outcome measures (3)
  • To study the effect of microbiota on the immune system [Time frame: 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. [Time frame: 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 [Time frame: October 2013 - October 2026]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • McMaster University — Hamilton

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06532110 · HiREB-15311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗