Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT06548399

Conditions

Inflammatory Bowel Diseases

Crohn's Disease

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases

Crohn's Disease

Ulcerative Colitis

Study ID

NCT06548399

Start date

Dec 1, 2023

Status verified date

Aug, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Gaston H Rueda, MD

905 521-2100ruedag@mcmaster.ca

Andrea Nardelli, MD

905-521-2100nardela@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8S 4L8

Contacts

Gaston H Rueda, MD

905 521-2100ruedag@mcmaster.ca

Andrea Nardelli, MD

905-521-2100nardela@mcmaster.ca

Principal Investigator:

Premysl Bercik, MD

More Information

Sponsor

McMaster University

Last update posted

Aug 12, 2024

Last verified

Aug, 2024

Keywords

  • longitudinal
  • IBD
  • bacteria
  • LPC
  • LPA
  • Chron's disease
  • Ulcerative colitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-08-12.