Inflammatory Bowel DiseasesLong-IBDNCT06548399
Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Crohn's Disease, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2024to 30 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of IBD: Crohn\'s disease or Ulcerative colitis followed at McMaster University's Gastroenterology Outpatient Clinic.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S 4L8
Jumanah Alawfi, RD, 905 521-2100 ext. 21875, alawfij@mcmaster.ca
Andrea Nardelli, MD, 905-521-2100 ext. 21922, nardela@mcmaster.ca
About this study
Official title: Bacterial Production of LPC and LPA and Symptoms Generation in Inflammatory Bowel Disease Patients With Chronic Abdominal Pain: a Longitudinal Exploratory Study
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.
Read the detailed description
The human body is inhabited by a complex community of microbes, collectively referred to as "microbiota". A vast majority of these bacteria are found in the lumen of the gastrontestinal tract (colon, small intestine, stomach and esophagus). Several lines of evidence indicate that changes in microbiota (bacteria) may be involved in the origin of different gastrointestinal diseases, including inflammatory Bowel Disease (IBD), with its two main types: Crohn´s disease and Ulcerative colitis.
Recent data suggest that the gut bacteria have the capability to produce lysophosphatidylcholine (LPC) and its derivative, lysophosphatidic acid (LPA), small lipid molecules that were shown previously to be involved in the genesis and maintenance of chronic pain. The investigators found that these molecules are higher in stool of patients with Inflammatory Bowel Disease (IBD), but it is unclear whether 1) they are produced by gut bacteria, and 2) whether their production underlies chronic pain in patients with IBD.
The purpose of this study is to determine whether the gut bacteria produce LPC and LPA and induce chronic abdominal pain, which is common in many patients with IBD, even when their colitis is in remission (absence of overt gut inflammation).
In this exploratory longitudinal study, the investigators will recruit patients with IBD, aged 18-70 years, of both sexes, with a history of moderate to severe chronic abdominal pain (as defined by their gastroenterologist), which persists during remission of colitis (absence of overt inflammation on CT or MRI imaging, and baseline fecal calprotectin less than 200 μg/g of stool) or while having only mild gut inflammation, defined by either colonoscopy (Endoscopic Mayo score: 0-1 or Simple Endoscopic Score for Crohn's Disease score: 0-10). We will recruit 15 patients with baseline stool LPC less that 200 μg/mg and LPA less than 100 μg/mg levels after first assessment in screening visit. Recruitment will take place at McMaster University IBD clinic (https://www.mcmasteribd.com).
After study participant meets the eligibility criteria and signs the informed consent, stool and urine samples will be collected and abdominal pain scores recorded for 3 weeks. Daily stool and urine samples (first stool of the day and morning (overnight) urine) will be collected, and LPC/LPA measured by ELISA. Abdominal pain will be assessed daily with a visual analogue scale (VAS). In addition, clinical symptoms will be evaluated by PROMIS (GI Belly Pain, Diarrhea, Constipation and Bloating) and DASS-21 questionnaires at the end of each week, as they assess symptoms during the preceding 7 days. Dietary intake will be assessed at the beginning of each week by a 3-day food diary. The clinical surveys will be provided online, using RedCap software and secure servers already operational within McMaster.
- Keywords
- longitudinal, IBD, bacteria, LPC, LPA, Chron's disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between daily abdominal pain and stool LPC/LPA levels
Measured: From enrolment to the end of data/sample collection period at 3 weeks
Secondary outcomes (2)
Correlation between daily abdominal pain and urine LPC/LPA levels
Measured: From enrolment to the end of data/sample collection period at 3 weeks
Correlation between daily abdominal pain and abundance of LPC/LPA producing bacteria in the stool
Measured: From enrolment to the end of data/sample collection period at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Dec 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Premysl Bercik, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548399
- Sponsor's protocol ID
- HiREB-16972
- Acronym
- Long-IBD
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.