260 Participants Needed

Gut Microbiome for Chronic GI Diseases

(ChronicGI Trial)

GR
PB
Overseen ByPremysl Bercik, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: McMaster University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore gut bacteria in individuals with chronic gastrointestinal (GI) issues such as IBS, IBD, and celiac disease. Researchers seek to understand how these bacteria might link to symptoms and changes in the gut and brain. Mice will also be used to better understand these connections. Individuals diagnosed with these GI conditions who have not recently used antibiotics or probiotics may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance the understanding and treatment of GI conditions.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot have taken antibiotics or probiotics in the last month.

Why are researchers excited about this trial?

Researchers are excited about studying gut microbiota's role in chronic gastrointestinal diseases because it explores a new frontier in understanding and potentially treating these conditions. Unlike standard treatments like anti-inflammatory drugs, immunosuppressants, and dietary interventions that mainly manage symptoms, this approach looks at the gut's bacterial balance to address root causes. By analyzing how gut bacteria influence conditions like IBD, IBS, and celiac disease, there's potential to develop more personalized and effective therapies, possibly reducing reliance on medications with significant side effects. This could revolutionize how we approach chronic GI issues, offering hope for better long-term outcomes.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing to participate in the clinical trial.
I have signed the informed consent form.
I have been diagnosed with a digestive condition like IBD, celiac disease, IBS, or a related issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Collection of stool, blood, and tissue samples from participants at a single time point during endoscopy/colonoscopy appointment

1 day
1 visit (in-person)

Translational Phase

Colonization of germ-free mice with human feces from patients and controls to compare symptoms, microbiota composition, and histological changes

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after sample collection and translational experiments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Endoscopy/Colonoscopy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Chronic gastrointestinal disordersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+