Who is eligible for clinical trial NCT06548399?

Participants must meet protocol criteria for Inflammatory Bowel Diseases. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06548399 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2024-08-07

Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease (NCT06548399)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: McMaster University

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (6 items).

Location: McMaster University — Hamilton, Ontario

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

McMaster University — Hamilton, Ontario

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗