Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease

NCT06548399 | Recruiting

• 1 other identifier: HiREB-16972
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation between daily abdominal pain and stool LPC/LPA levels

  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

  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

  From enrolment to the end of data/sample collection period at 3 weeks

Other Outcomes (1)

• Associations between weekly average stool LPC/LPA levels and overall gastrointestinal symptoms, anxiety, depression and stress.

  From enrolment to the end of data/sample collection period at 3 weeks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool and urine samples will be collected every day for the week periods 1, 2 and 3. Stool and urine samples will be aliquoted in 2mL sterile tubes in anaerobic (in the case of stool samples) and sterile conditions, for future analysis. Samples will be stored in - 81 freezer located in room 4N30, at McMaster University Medical Centre.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Gaston H Rueda, MD

CONTACT

905 521-2100; ruedag@mcmaster.ca

Andrea Nardelli, MD

CONTACT

905-521-2100; nardela@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: December 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

CA (1)