RecruitingNAINTERVENTIONAL

Effect of Chronic Feeding of Inulin And Methylcellulose on Colonic Fermentation

This study wants to learn how different dietary fibres affect gas in the gut, especially for people with Irritable Bowel Syndrome (IBS). The main goal is to find ways to reduce uncomfortable bloating and other symptoms. Researchers are testing a combination of two types of fibre: inulin, which is fermented in the gut, and methylcellulose, which forms a gel. They want to see if taking these together every day for two weeks helps more than taking a simple sugar called maltodextrin, which doesn't affect the gut in the same way. The study aims to understand if this fibre mix helps improve how well people tolerate inulin and reduces gas production over time.

At a glance

Status

Recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

Start

30 Sep 2024

Estimated completion

30 Jun 2025

Irritable Bowel Syndrome

What is this study about?

Our research wants to understand how different kinds of fibre in your diet work together in your gut, especially for people who experience Irritable Bowel Syndrome (IBS). Many foods contain things called FODMAPs, which some gut bacteria love to munch on, creating gas. This gas can cause uncomfortable bloating and other IBS symptoms. We've previously learned that certain gel-forming fibres, like psyllium, can help reduce this gas. Now, we're exploring if other similar fibres can have the same helpful effect.

This study specifically looks at a combination of two fibres: inulin and methylcellulose. Inulin is a type of fibre that gut bacteria ferment, which can sometimes lead to gas. Methylcellulose is a fibre that forms a gel in the gut. We want to see if combining these two and taking them regularly—daily for two weeks—can help reduce gas and improve how well people tolerate the inulin. We're comparing this fibre mix to a placebo, which is a common sugar called maltodextrin. Maltodextrin is quickly absorbed by your body and doesn't affect your gut in the way these fibres do.

The main aim is to see if this daily fibre combination can change how your gut processes these substances, ideally leading to less gas and more comfortable symptoms for people with IBS. Previous studies often looked at single doses, but we believe taking them regularly might have a different, more beneficial impact on your gut and its symptoms.

Key takeaways

This study investigates fibre mixes for IBS symptoms.
It tests inulin and methylcellulose against a placebo (maltodextrin).
Participation involves daily consumption of assigned substances for two weeks.
Aims to reduce gas and bloating in people with mild IBS.
Includes regular assessments like breath sampling.

Who may be eligible?

To be part of this study, you need to be a healthy adult aged between 18 and 65 years old. You should have some mild IBS symptoms, like a bit of bloating or gas, but not really severe ones. It's important that you're able to understand and agree to the study plan and eat the meals provided during the trial.

There are some reasons why you wouldn't be able to join. For example, if you are pregnant, breastfeeding, or planning to get pregnant. You also can't have other serious gut problems or have had certain surgeries on your stomach or intestines. If you have conditions like severe diabetes, or if you're taking medicines that change how your gut works, you might not be eligible. Your body weight must also be within a certain range.

We also need you to understand English well to follow the instructions and be able to participate fully in the study without working night shifts right before the study days. If you're currently taking antibiotics or probiotics, you won't be able to join because these can affect your gut bacteria, which is what we're studying.

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.

Am I between 18 and 65 years old?
Do I have mild IBS symptoms (not severe)?
Am I pregnant, breastfeeding, or planning pregnancy?
Do I have any other serious gut problems or medical conditions?
Am I currently taking antibiotics or probiotics?
Can I commit to taking the study substance daily for two weeks and follow a diet?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to consume a mix of inulin and methylcellulose (or a placebo, maltodextrin) daily for two weeks. This will be divided into three portions to be taken before breakfast, lunch, and supper. In the first week, each portion will be smaller (2.5g of each fibre in a small amount of water), and in the second week, the portions will be larger (5.0g of each fibre in a bit more water). Throughout the study, you'll also be asked to follow a specific dietary plan.

The study involves regular check-ups and assessments, which might include giving breath samples. This helps us measure the gas produced in your gut. You will need to agree not to smoke during these breath sampling periods. The entire study period is two weeks of taking the mixture daily, plus any necessary appointments for assessments before and after. The researchers will explain all the visits and tests in detail.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a better understanding of how certain fibres affect your gut and symptoms. While we don't expect major risks, some people might experience temporary side effects like changes in bowel habits or increased gas as your gut adjusts to the fibres. All substances used are food-grade. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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· Recruiting
Nottingham Digestive Diseases Centre
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What are inulin and methylcellulose?

They are both types of fibre. Inulin is found in many plants and gets fermented by gut bacteria. Methylcellulose is a fibre that forms a gel when mixed with water.

What is maltodextrin?

It's a type of sugar often used in foods. In this study, it's used as a placebo, meaning it's a comparison to the active fibres because it doesn't affect the gut in the same way.

How long will I take these substances?

You will take the assigned substance daily for a period of two weeks.

Will I know if I'm getting the fibre mix or the placebo?

No, this is usually a 'blinded' study, meaning neither you nor the research team will know what you are taking until after the study is complete, to keep the results unbiased.

What are FODMAPs?

FODMAPs are specific types of carbohydrates found in various foods. They can be fermented by gut bacteria and sometimes cause gas and bloating in sensitive individuals.

How to find out more

Alsion Thorpe, MD

alison.thorpe@nottingham.ac.uk +44 (0)115 7486731 Official trial record

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