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OpenTrials
Recruiting

NCT Number: NCT06532110

Gut Microbiota in Chronic GI Diseases

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.

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopy/Colonoscopy

Other

Esophagogastroduodenoscopy and colonoscopy with video recording and biopsy collection

Primary outcomes

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

    Time frame: October 2013 - October 2026

    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.

Secondary outcomes

  1. To study the effect of microbiota on the immune system

    Time frame: October 2013 - October 2026

    Through colonization of germ free mice with human feces from the different groups of patients and controls.

  2. 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

    Assessed by stool samples and aspirates, representative to the luminal composition; and the intestinal tissue (biopsies) representative of the mucosa

  3. 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

    Through assessing different bacteria derived metabolites, such as short-chain fatty acids

Study contacts

Contact information is provided by the study sponsor or research team.

Gaston Rueda, MD

CONTACT

[email protected]

9055212100 ext. 21875

Premysl Bercik, MD

CONTACT

[email protected]

905 521 2100 ext. 73495

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: ChronicGI

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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