Status:
RECRUITING
Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
Lead Sponsor:
McMaster University
Conditions:
Inflammatory Bowel Diseases
Crohn's Disease
Eligibility:
All Genders
18-70 years
Brief Summary
The purpose of this study is to investigate whether the gut bacteria in IBD patients cause ongoing abdominal pain, even when the disease is calm. Many inflammatory bowel disease (IBD) patients have th...
Detailed Description
The human body is inhabited by a complex community of microbes, collectively referred to as "microbiota". A vast majority of these bacteria are found in the lumen of the gastrontestinal tract (colon, ...
Eligibility Criteria
Inclusion
- 18 and 70 years of age
- Crohn's disease diagnosis with history of past or current moderate or severe chronic abdominal pain that persist despite colitis being in remission (absence of overt inflammation on CT or MRI imaging, and baseline fecal calprotectin of less than 200 μg/g of stool), or in presence of mild inflammation defined by colonoscopy (Simple Endoscopic Score for Crohn's Disease score: 0-10),
- Ulcerative colitis diagnosis with history of past or current moderate or severe chronic abdominal pain that persist despite colitis being in remission (absence of overt inflammation on CT or MRI imaging, and baseline fecal calprotectin less than 200 μg/g of stool) or in presence of mild inflammation defined by colonoscopy (Endoscopic Mayo score: 0-1)
Exclusion
- Current acid anti-secretory and antacid medications
- Antibiotics, antibacterial agents or probiotics, currently, or within the last 8 weeks
- Current pain treatment with opioids or NSAIDs (acetaminophen is permitted)
- Alcohol or drug abuse
- Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06548399
Start Date
December 1 2023
End Date
December 1 2024
Last Update
August 12 2024
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8S 4L8