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Chronic gastrointestinal disorders for Microbiome (ChronicGI Trial)

N/A
Recruiting
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up october 2013 - october 2026
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~october 2013 - october 2026
This trial's timeline: 3 weeks for screening, Varies for treatment, and october 2013 - october 2026 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To identify different patterns of intestinal microbiota in patients diagnosed with chronic gastrointestinal disorders or controls
Secondary study objectives
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
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.
To study the effect of microbiota on the immune system

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chronic gastrointestinal disordersExperimental Treatment1 Intervention
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)

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Who is running the clinical trial?

McMaster UniversityLead Sponsor
906 Previous Clinical Trials
2,612,981 Total Patients Enrolled
~37 spots leftby Oct 2026
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