Investigating gut bacteria's role in abdominal pain for IBD patients
Official title: Bacterial Production of LPC and LPA and Symptoms Generation in Inflammatory Bowel Disease Patients With Chronic Abdominal Pain: a Longitudinal Exploratory Study
Run by McMaster University · NCT06548399 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | December 1, 2024 |
| Main results expected | March 30, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT06548399 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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McMaster University
Hamilton, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Jumanah Alawfi, RD
- Email: alawfij@mcmaster.ca
- Phone: 905 521-2100
Similar studies
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This study tests ATH-063 to see if it helps people with moderate to severe ulcerative colitis who did not respond to or relapsed after prior biologic therapy.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.