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

August 7, 2024 updated by: Premysl Bercik, McMaster University

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.

Study Overview

Status

Recruiting

Conditions

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.

Our recent data suggest that the gut bacteria have the capability to produce lysophosphatidylcholine (LPC) and its derivative, lysophosphatidic acid (LPA), small lipid molecules that are were shown previously to be involved in the genesis and maintenance of chronic pain. We 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 our 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, we 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 <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 >200 μg/mg and LPA >100 μg/mg levels after first assessment in screening visit. Recruitment will take place at McMaster University IBD clinic, currently caring for over 1600 patients with IBD (https://www.mcmasteribd.com).

After study participant meets the eligibility criteria and signs the informed consent, we will collect stool and urine samples and abdominal pain scores for 3 weeks, Monday to Friday each week. 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.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • Recruiting
        • McMaster University
        • Principal Investigator:
          • Premysl Bercik, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of IBD: Crohn's disease or Ulcerative colitis followed at McMaster University's Gastroenterology Outpatient Clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between daily abdominal pain and stool LPC/LPA levels
Time Frame: From enrolment to the end of data/sample collection period at 3 weeks
From enrolment to the end of data/sample collection period at 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between daily abdominal pain and urine LPC/LPA levels
Time Frame: From enrolment to the end of data/sample collection period at 3 weeks
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
Time Frame: From enrolment to the end of data/sample collection period at 3 weeks
From enrolment to the end of data/sample collection period at 3 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Associations between weekly average stool LPC/LPA levels and overall gastrointestinal symptoms, anxiety, depression and stress.
Time Frame: From enrolment to the end of data/sample collection period at 3 weeks
From enrolment to the end of data/sample collection period at 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HiREB-16972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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