Crohn'sUCRecruiting
Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · McMaster University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Diseases, Crohn's Disease and Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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…
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- Start date: 2024-12-01.
- Main results expected around 2027-03-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Correlation between daily abdominal pain and stool LPC/LPA levels (From enrolment to the end of data/sample collection period at 3 weeks)
In the researchers’ words
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.
Words you might see
- Fecal calprotectin: a stool test that measures inflammation in the gut.
- Colonoscopy: a camera exam of the large intestine (colon).
- Endoscopy: a camera exam inside the digestive tract.
- Mayo score: a score used to measure how active ulcerative colitis is.
- Remission: a period when the disease is quiet or under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis |
| Lead sponsor | McMaster University |
| Enrollment | 15 (estimated) |
| Start date | 2024-12-01 |
| Primary completion (est.) | 2027-03-30 |
| First posted | 2024-08-12 |
| Last updated | 2026-10-01 |
| Official title | Bacterial Production of LPC and LPA and Symptoms Generation in Inflammatory Bowel Disease Patients With Chronic Abdominal Pain: a Longitudinal Exploratory Study |
| ClinicalTrials.gov ID | NCT06548399 |
Interventions
- None listed
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University | Hamilton, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.