Not yet recruitingNAINTERVENTIONAL

Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin

This study aims to understand how certain natural fibres, specifically methylcellulose and psyllium, can affect gas production in the gut. These fibres are known for forming a gel, and researchers want to see if taking them before a fermentable fibre called inulin can help reduce discomfort for people with Irritable Bowel Syndrome (IBS). In previous studies, these fibres were mixed together, but this time they are being given separately. The main goal is to test if taking the gel-forming fibres first changes how the body handles inulin, potentially leading to less gas. We'll compare the effects of methylcellulose and psyllium against a dummy treatment (water) to see how well they work.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Mar 2025

Irritable Bowel Syndrome

What is this study about?

Many people with Irritable Bowel Syndrome (IBS) experience uncomfortable symptoms like bloating and gas. These symptoms can often be caused by certain fibres found in food, called FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols), which are broken down by bacteria in the gut, producing gas. We've seen in past research that natural fibres like psyllium, which form a gel when mixed with water, can help reduce gas when taken at the same time as a FODMAP fibre called inulin.

This new study builds on that knowledge. Instead of mixing the fibres, we want to see what happens if the gel-forming fibres (methylcellulose or psyllium) are taken *before* the inulin. We're testing if this different timing can change how the body processes the inulin, potentially leading to less gas production in the gut. Understanding how these fibres interact is important because it could lead to better ways to manage IBS symptoms.

We don't yet fully understand *how* methylcellulose and psyllium help. It could be that they slow down how quickly the inulin reaches the gut, or prevent it from being released too fast. It's also possible they directly affect the gut bacteria, making them produce less gas. By carefully studying this, we hope to find new ways to help people with IBS feel more comfortable.

Key takeaways

The study investigates how natural fibres (methylcellulose, psyllium) affect gut gas.
It focuses on people with mild IBS symptoms, specifically gas and bloating.
Participants will take a gel-forming fibre *before* another fibre called inulin.
Researchers will measure breath gases to see changes in gut fermentation.
The goal is to find better ways to manage IBS discomfort.
This is a pilot study, meaning it's an early investigation.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old and be able to understand and agree to take part. You should also have fairly mild stomach symptoms like mild bloating, gas, or pain, scoring 5 or less on a special symptom scale over the last two weeks.

There are several reasons why someone might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant, you cannot participate. Also, if you have a history of serious gut problems, have had stomach or bowel surgery (except for appendix removal), or have certain medical conditions like diabetes that might affect the study, you would not be eligible. We also can't include people who are taking antibiotics or probiotics, or those who find it hard to understand English.

Your doctor will help confirm if you can safely take part. It's important that you don't take certain medications that affect gut movement, like specific pain relievers or antidepressants, for the duration of the study. You also shouldn't be smoking during the breath tests, and will need to generally follow a specific diet and lifestyle during the study period.

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 65 years old?
Do you have mild IBS symptoms (like mild gas or bloating), not severe?
Are you not pregnant, breastfeeding, or planning a pregnancy?
Do you not have a history of serious bowel conditions or surgeries (besides appendix removal)?
Are you able to speak and understand English clearly?
Are you willing and able to follow specific diet and medication instructions for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to visit the research clinic on a few occasions. During these visits, you will be given either the methylcellulose, psyllium, or a placebo (water) to take before a dose of inulin. We will then measure the gases you breathe out, particularly hydrogen, over six hours to see how your body is processing the inulin. We might also collect other information like breath methane levels. You will be asked to follow specific dietary instructions and might need to avoid certain medications before and during the study. The total duration of your involvement will depend on the study schedule, but each testing day typically involves a six-hour monitoring period after taking the inulin. You will be asked not to smoke during these breath test periods.

Potential risks and benefits

Participating in this study might help us understand more about how these fibres can reduce gas and discomfort in people with IBS, which could ultimately lead to better treatments. You might personally experience some relief from your symptoms during the study, but this is not guaranteed as it's a research study. Potential risks are generally low, as the fibres used are common, but there's always a chance of mild stomach upset or other reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nottingham Digestive Disease Centre
Verified postcode
Nottingham, United Kingdom

Common questions

What is inulin?

Inulin is a type of natural fibre found in many plants, like chicory root. It's also a FODMAP, which means it can be fermented by gut bacteria and sometimes cause gas and bloating.

What are methylcellulose and psyllium?

Methylcellulose and psyllium are both natural fibres that form a gel when mixed with water. They are often used as fibre supplements and can help soften stools and promote bowel regularity.

What does 'pre-dosing' mean?

'Pre-dosing' means taking one substance (like methylcellulose or psyllium) before taking another substance (like inulin). In this study, we want to see if taking the gel-forming fibres first changes their effect.

What is a 'placebo'?

A placebo is a dummy treatment, often just water, given to some participants. This helps researchers compare the effects of the active treatments against no treatment to see if they truly work.

Why will you measure my breath?

When certain fibres are broken down by gut bacteria, they produce gases like hydrogen. By measuring these gases in your breath, we can understand how much of the fibre is being fermented in your gut.

How to find out more

Robin Spiller, MD

robin.spiller@nottingham.ac.uk 07824328319 Official trial record

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