Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
Recruiting · NCT06548399 · Observational (researchers observe without assigning treatment) · Lead sponsor: McMaster University
View the official record on ClinicalTrials.gov →What this trial is about
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 this pain, regardless of whether their disease is active or not. This might be linked to an imbalance in gut bacteria. Certain IBD patients with persistent abdominal pain experience increased sensitivity in their gut due to bacteria producing LPC and LPA. Our goal is to explore the connection between bacterial LPC/LPA levels and symptoms in IBD patients with long-lasting abdominal pain. Additionally, we aim to pinpoint the specific bacteria responsible for producing LPC/LPA, which in turn causes chronic abdominal pain in these patients.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed.
- McMaster University - Hamilton, Ontario, Canada
- McMaster University - Hamilton, Ontario, Canada