Gut Microbiome Analysis for Crohn's Disease

(OPTIMIST Trial)

Overseen By Mackenzie Melvin, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Antibiotics, Prebiotics, Probiotics, Postbiotics

Disqualifiers: Active perianal CD, Colorectal cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain patterns in the gut microbiome (the bacteria and other tiny organisms living in the gut) can predict treatment effectiveness for people with Crohn's disease. Researchers will collect samples from individuals with both active and inactive Crohn's disease and compare them to those without the condition. Participants must have Crohn's disease affecting the lower digestive tract and be scheduled for a routine colonoscopy. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment strategies for Crohn's disease.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you've taken antibiotics in the last 3 months or prebiotic, probiotic, or postbiotic supplements in the last month.

What prior data suggests that colonoscopy is safe for patients with Crohn's disease and non-IBD controls?

Research has shown that colonoscopies are generally safe for people with Crohn's disease. Studies indicate that the risks of bleeding or tearing after a colonoscopy are not higher in patients with inflammatory bowel disease (IBD), which includes Crohn's disease. In fact, some studies suggest these risks might be lower in people with IBD compared to those without it. Bleeding and tearing are rare overall, making colonoscopies well-tolerated for most patients.

Additionally, recent colonoscopies have been linked to a lower risk of colorectal cancer in people with IBD, offering benefits beyond just monitoring the disease. This procedure is usually part of routine care for those with Crohn's disease, so those considering joining a study involving colonoscopy can be assured of its well-established safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Crohn's disease, which often involve medication or surgery to manage symptoms and inflammation, this trial is exploring how analyzing the gut microbiome can predict treatment outcomes. Researchers are excited about this trial because it aims to uncover how the unique bacteria in a person's gut might influence their response to Crohn's disease treatment. By understanding these gut bacteria better, doctors might be able to personalize treatment plans, potentially leading to more effective outcomes with fewer side effects. This could be a game-changer in managing Crohn's disease, making treatment more tailored and effective for each individual.

Are You a Good Fit for This Trial?

Inclusion Criteria

My Crohn's disease is active, shown by a high score on a specific test and at least one large ulcer.

I have Crohn's disease.

My Crohn's disease is currently inactive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Pilot Study

Evaluate the microbiome in patients with IBD (active and quiescent) and non-IBD controls

Not specified

1 visit (in-person) for sample collection during routine colonoscopy

Longitudinal Observational Study

Participants provide samples and are monitored for microbiome signatures predicting therapy response

12 months

Multiple visits (in-person) for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after the main observational study

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Colonoscopy

How Is the Trial Designed?

Group I: Patients without inflammatory bowel disease Experimental Treatment 1 Intervention

The study will include 25 non-IBD age and sex-matched controls to compare data alongside the CD patients. These patients will be undergoing routine colonoscopy as per their normal colon screening routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope.

Group II: Patients with Crohn's disease Experimental Treatment 1 Intervention

The study will include 75 consenting patients with Crohn's disease, varying in levels of severity depending on assigned SES-CD scoring from their gastroenterologist. These patients will be undergoing routine colonoscopy as per their normal care routine, with this study not requiring additional scheduling commitments. Blood, mucosal washing, and intestinal biopsy samples will be collected during routine colonoscopy procedure. The patient will have the option to collect a stool sample the day before their colonoscopy and bring it to their appointment. They will also receive a sample collection kit during their appointment to collect their next required stool sample in two weeks after their scope.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

IBD Centre of BC

Collaborator

Trials

1

Recruited

100+

GI Research Institute

Collaborator

Trials

1

Recruited

100+

Pacific Gastroenterology Associates

Collaborator

Trials

1

Recruited

100+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4297589/

Colonoscopy is Associated with a Reduced Risk for Colon ...

Recent colonoscopy (within 36 months) is associated with a reduced incidence of CRC in patients with IBD, and lower mortality in those diagnosed with CRC.

2.

cghjournal.org

cghjournal.org/article/S1542-3565(24)01073-5/fulltext

Comparative Efficacy and Safety of Endoscopic Modalities ...

The risk of CRC escalates with the duration of IBD, contributing to 10% to 15% of all-cause mortality among these patients.

3.

academic.oup.com

academic.oup.com/ecco-jcc/article/17/12/1962/7219030

Inflammatory Bowel Disease Is not Linked to a Higher Rate of ...

Overall, these data would suggest that IBD is not associated with higher risk of bleeding or perforation after a single colonoscopy. However ...

4.

medpagetoday.com

medpagetoday.com/resource-centers/crohns-disease-update/do-ibd-patients-suffer-more-complications-colonoscopy/4754

Do IBD Patients Suffer More Complications From ...

Rates of bleeding and perforation were found to be lower in patients with IBD than in those without IBD. Bleeding and perforation are rare ...

5.

gastrojournal.org

gastrojournal.org/article/S0016-5085(22)00078-6/fulltext

Disease Monitoring in Inflammatory Bowel Disease

In this review we discuss the current monitoring tools available to us and how they can be used. We also discuss the importance of monitoring during key phases ...