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RecruitingPHASE1INTERVENTIONAL

Impact of PEG Bowel Preparation on Gut Microbiome Composition Recovery

This study investigates how a medication called PEGLyte, used to clean out your bowels, impacts the natural balance of good bacteria and other germs in your gut, known as your gut microbiome. Researchers want to see exactly how PEGLyte changes this balance and how quickly your gut returns to normal afterwards. This information is important because some scientists believe these changes could affect how well certain cancer treatments work, while others think it might be a good standard for future research. By understanding these effects, scientists can design better studies in the future, particularly those focusing on the gut microbiome and its role in health and disease.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Enrolment target
20
Start
05 Dec 2024
Estimated completion
05 Dec 2026

What is this study about?

This research study is looking into something called the 'gut microbiome'. This is the name for all the tiny living things, like bacteria, that live in your intestines and help you digest food and stay healthy. Before certain medical procedures, like colonoscopies, people often drink a special solution, such as PEGLyte, to completely clear out their bowels.

The study wants to understand exactly how this bowel-cleansing drink affects your gut microbiome. Researchers will look at what kind of germs are there, how many different kinds there are, and what chemicals they produce. They also want to see how quickly your gut microbiome gets back to its normal state after you've taken the drink.

Why does this matter? Well, some doctors believe that using PEGLyte and not putting those germs back (for example, through a faecal transplant) could be a good way to compare treatments in future studies. However, others are concerned that changing the gut microbiome with PEGLyte might affect how well some cancer treatments work. By doing this study, using advanced genetic testing, we can get a much clearer picture of what's happening in the gut. This will help scientists design better research in the future, especially studies that look at our gut germs and how they affect our health and treatments.

Key takeaways

  • The study explores how bowel cleansing drinks affect your gut's natural germs.
  • It aims to understand these changes and how quickly your gut recovers.
  • This research could help improve future medical studies and treatments.
  • It's for healthy volunteers aged 18 to 70.
  • You'll need to take a bowel cleansing drink and provide stool samples.

Who may be eligible?

This study is looking for healthy volunteers aged 18 to 70 years old. To join, you need to understand the study and agree to take the PEGLyte bowel preparation and provide stool samples as requested.

There are several reasons why you might not be able to join. For example, if you have certain bowel problems like a blockage or inflammation, or if you've recently had cancer treatment or taken antibiotics in the last month. People with heart or kidney problems might also not be able to take part.

Also, if you have trouble swallowing safely or if there's any other medical reason why you shouldn't take PEGLyte according to its instructions, then this study might not be right for you.

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.

  1. Are you between 18 and 70 years old?
  2. Are you generally healthy and not currently undergoing cancer treatment?
  3. Have you not taken antibiotics in the last month?
  4. Do you not have serious bowel, heart, or kidney problems?
  5. Can you safely take bowel cleansing medication?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will need to give your informed consent, which means you'll read and understand what's involved and agree to participate. You will be asked to take the PEGLyte bowel preparation drink, which helps to clear out your bowels. Throughout the study, you will need to collect and provide stool (poo) samples. The researchers will then analyse these samples to understand the changes in your gut microbiome. The exact number of visits, specific timing for assessments, and the overall length of your participation will be explained in detail by the study team.

Potential risks and benefits

Participating in this study will help researchers understand the impact of bowel preparation on gut health, which could lead to better designs for future medical studies and potentially improve treatments for various conditions. However, taking the PEGLyte bowel preparation can cause side effects such as nausea, bloating, and needing to use the toilet frequently. There are also very rare risks associated with any medical procedure. You have the right to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

  • Centre hospitalier de l'Université de Montréal (CHUM)
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is the 'gut microbiome'?

It's the name for all the tiny living things, like bacteria and fungi, that live in your intestines and help keep you healthy.

What is PEGLyte?

It's a special drink used to clean out your bowels, often before medical procedures like colonoscopies.

Why are you studying this?

We want to understand how bowel-cleansing drinks affect the good germs in your gut and how quickly your gut recovers, which helps in designing better future research.

Will I get paid to participate?

The information provided does not state whether participants will be paid. You should ask the study team about any compensation.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Wiam Belkaid, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Impact of PEG Bowel Preparation on Gut Microbiome Compositio…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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