Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients with a diagnosis of IBD: Crohn\'s disease or Ulcerative colitis followed at McMaster University's Gastroenterology Outpatient Clinic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Correlation between daily abdominal pain and stool LPC/LPA levels
Time frame
From enrolment to the end of data/sample collection period at 3 weeksSecondary outcomes
1
Correlation between daily abdominal pain and urine LPC/LPA levels
Time frame
From enrolment to the end of data/sample collection period at 3 weeks2
Correlation between daily abdominal pain and abundance of LPC/LPA producing bacteria in the stool
Time frame
From enrolment to the end of data/sample collection period at 3 weeksOther outcomes
1
Associations between weekly average stool LPC/LPA levels and overall gastrointestinal symptoms, anxiety, depression and stress.
Time frame
From enrolment to the end of data/sample collection period at 3 weeksSponsors and contacts
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Source ClinicalTrials.gov