RecruitingOBSERVATIONAL

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

This study aims to understand why many people with Crohn's disease and ulcerative colitis still suffer from tummy pain, even when their disease isn't flaring up. Researchers believe that certain gut bacteria might be involved. They are particularly interested in two types of fatty molecules, called LPC and LPA, which these bacteria may produce. Earlier research suggests that higher levels of these molecules are found in the stools of people with Inflammatory Bowel Disease (IBD). The study wants to confirm if bacteria are indeed making these molecules and if these molecules are directly causing the long-lasting tummy pain in IBD patients. They also hope to identify the specific types of bacteria responsible for this.

At a glance

Status

Recruiting

Sponsor

McMaster University

Enrolment target

Start

01 Dec 2023

Estimated completion

01 Dec 2024

Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis

What is this study about?

Imagine your tummy has its own little world of tiny living things, mostly bacteria, called your 'gut microbiota'. For people with types of Inflammatory Bowel Disease (IBD), like Crohn's disease and ulcerative colitis, this group of bacteria can sometimes get out of balance. This imbalance is thought to play a role in why these conditions start.

Even when their IBD is calm and not causing inflammation, many patients still experience ongoing tummy pain. Our recent findings suggest that certain gut bacteria might be producing small fatty molecules, called LPC and LPA. We've seen higher levels of these molecules in the stools of IBD patients. Scientists have also linked these specific molecules to long-lasting pain in other situations. Now, we want to find out if these gut bacteria are indeed making LPC and LPA, and if these molecules are the reason for the persistent tummy pain in people with IBD.

This study will help us explore the link between these bacterial molecules and symptoms in IBD patients who have ongoing tummy pain. We also hope to identify exactly which types of bacteria are responsible for making LPC and LPA. Understanding this could open doors for new ways to help manage chronic abdominal pain for people living with IBD.

Key takeaways

Aims to understand ongoing tummy pain in IBD, even during remission.
Investigates if gut bacteria produce certain fats (LPC, LPA) linked to this pain.
Researchers want to identify which specific bacteria might be responsible.
No new treatments are given; it's an observational study.
Could help find new ways to manage IBD pain in the future.

Who may be eligible?

You might be able to take part in this study if you are between 18 and 70 years old. You need to have been diagnosed with either Crohn's disease or ulcerative colitis. A key part of joining is that you experience moderate to severe tummy pain that has been ongoing, even when your IBD is considered to be 'in remission' – meaning there are no signs of major inflammation in your gut using tests like scans or stool samples. You could also be eligible if you have only very mild inflammation that your doctor has identified during a colonoscopy.

There are also some reasons why you might not be able to join. For example, if you are currently taking certain medications like strong antacids, antibiotics, or probiotics. You also cannot be taking opioid pain medications or most anti-inflammatory pain medications (NSAIDs), although paracetamol is allowed. You also shouldn't have issues with alcohol or drug abuse, or other serious health conditions that the study doctors think could affect your safety or the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have Crohn's disease or ulcerative colitis?
Do you experience ongoing moderate to severe tummy pain, even when your IBD is calm or only mildly inflamed?
Are you currently NOT taking antibiotics, probiotics, antacids, or strong pain medications like opioids or most NSAIDs?
Do you have a diagnosis of Crohn's disease with a Simple Endoscopic Score for Crohn's Disease score: 0-10, OR Ulcerative colitis with an Endoscopic Mayo score: 0-1?

Answer every question to see your result.

What does participation involve?

This study is an 'exploratory longitudinal study,' which means we will follow a small group of people over time to learn more. If you decide to take part, you will be asked to attend an initial screening visit. During this visit, we will check your eligibility, including a stool sample to measure levels of LPC and LPA. If your levels meet the study criteria, you will be invited to participate further.

Potential risks and benefits

By taking part in this study, you won't directly receive treatment for your IBD pain, as this is an observational study. However, the information gathered could significantly help other people with IBD in the future by leading to a better understanding and potentially new ways to manage chronic pain. All steps will be taken to ensure your safety and comfort during the study. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

McMaster University
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What are LPC and LPA?

LPC and LPA are specific types of fatty molecules that are naturally present in the body. In this study, we're looking at whether gut bacteria might be producing them and if they are linked to pain.

Does this study involve new medication?

No, this study does not involve taking any new medication. It's an observational study where we gather information through tests and assessments.

What if my IBD flares up during the study?

The study is focused on pain during remission or mild inflammation. If your condition changes, you should discuss this with your study team and your regular doctor.

How long will I be in the study?

The study is described as 'longitudinal,' meaning it involves following participants over a period. The exact duration for each participant will be explained by the study team.

Will I get paid to participate?

The study details don't mention payment. This is something you should clarify with the study team if you are interested.

How to find out more

Gaston H Rueda, MD

ruedag@mcmaster.ca 905 521-2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.