Investigating gut bacteria's role in abdominal pain for IBD patients

Bacterial Production of LPC and LPA and Symptoms Generation in Inflammatory Bowel Disease Patients With Chronic Abdominal Pain: a Longitudinal Exploratory Study

This study is trying to see if certain gut bacteria are linked to ongoing abdominal pain in people with inflammatory bowel disease, even when their symptoms are under control.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: McMaster University (other)
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT06548399 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between gut bacteria and chronic abdominal pain in patients with inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis. It will assess whether these bacteria produce lysophosphatidylcholine (LPC) and lysophosphatidic acid (LPA), which may contribute to ongoing pain even when the disease is in remission. The study will recruit patients aged 18-70 who have a history of moderate to severe chronic abdominal pain, and will analyze stool samples to identify bacterial production of LPC and LPA. The goal is to better understand the microbiota's role in IBD-related pain and identify specific bacteria involved.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of Crohn's disease or ulcerative colitis and a history of moderate to severe chronic abdominal pain persisting during remission.

Not a fit: Patients currently taking acid anti-secretory medications, antibiotics, or pain treatments such as opioids or NSAIDs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new insights into managing chronic abdominal pain in IBD patients, potentially improving their quality of life.

How similar studies have performed: While the specific approach of linking gut bacteria to chronic pain in IBD is exploratory, previous studies have indicated a connection between microbiota and gastrointestinal diseases, suggesting potential for success.

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

Where this trial is running

Hamilton, Ontario

• McMaster University — Hamilton, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: Gaston H Rueda, MD

Conditions: Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, longitudinal, IBD, bacteria, LPC, LPA