NCT06548399 Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
| NCT ID | NCT06548399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Inflammatory Bowel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2023-12-01 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06548399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06548399 currently recruiting?
Yes, NCT06548399 is actively recruiting participants. Contact the research team at ruedag@mcmaster.ca for enrollment information.
Where is the NCT06548399 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT06548399 clinical trial?
NCT06548399 is sponsored by McMaster University. The trial plans to enroll 15 participants.