Investigating the role of gut bacteria in Crohn's disease inflammation
Investigating the Relationship Between Inflammation and Proteolytic Activity from Mucosa-associated Microbiota in Crohn's Disease Patients
This study is trying to see how changes in gut bacteria might affect inflammation in people with Crohn's disease to help improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06503081 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between altered gut microbiota and inflammation in patients with Crohn's disease (CD). It focuses on characterizing the proteolytic activity associated with mucosal inflammation and how this may be modulated by bacteria that produce protease inhibitors, such as serpins. Patients aged 18 to 70 with a confirmed diagnosis of CD will undergo routine white light colonoscopy to assess disease activity and extent. The study seeks to understand the mechanisms behind increased proteolytic activity in CD and its implications for treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of Crohn's disease requiring a colonoscopy.
Not a fit: Patients with serious life-threatening co-morbidities or those who have taken antibiotics or probiotics recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for managing Crohn's disease by targeting gut microbiota.
How similar studies have performed: Other studies have shown promising results in understanding the role of gut microbiota in inflammatory bowel diseases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be aged between 18 - 70 years old * Have a confirmed diagnosis of Crohn's disease * Have a clinical indication for standard, white light colonoscopy to assess disease activity and extent Exclusion Criteria: * Inability to provide written informed consent * Presence of serious life-threatening co-morbidities * Evidence of toxic megacolon, jaundice, cirrhosis, renal dysfunction, acute GI bleeding * History of difficult colonoscopy, strictures or extensive diverticulosis * Antibiotics in the last month * Probiotics in the last week
Where this trial is running
Hamilton, Ontario
- McMaster University — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: David Armstrong, MB BChir
- Email: armstro@mcmaster.ca
- Phone: 905-521-2100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.