RecruitingNAINTERVENTIONAL

The 8x5 Diet for Bile Acid Diarrhoea: A Feasibility Randomised Controlled Trial

Bile Acid Diarrhoea (BAD) often causes long-lasting watery diarrhoea, and for many, common medicines don't fully help. Researchers have developed 'The 8x5 Diet' based on what they've learned about how diet can affect gut problems and food sensitivities. This study is a trial to check if it's possible to run a larger, more definite study on this diet. We'll recruit 76 adults across the UK who have BAD and ongoing diarrhoea. They will either stick to their usual diet or try The 8x5 Diet with dietitian support for eight weeks. The main goal is to see how easy it is to find participants, get their consent, assign them to groups, and keep them in the study. This will help us plan future research to see if The 8x5 Diet can really make a difference.

At a glance

Status

Recruiting

Phase

Sponsor

University of Manchester

Enrolment target

Start

02 Apr 2024

Estimated completion

31 Mar 2025

Bile Acid Diarrhea

What is this study about?

Bile Acid Diarrhoea (BAD) is a common condition in the UK, affecting about 1 in 100 adults. It causes really bothersome, often urgent, watery diarrhoea that can last a long time. While there are daily medicines, about half of people find their symptoms aren't well controlled. This means there's a real need to find other ways to help people feel better. Researchers have found that many people with BAD feel certain foods upset their tummy, and studies suggest that changes to fat and carbohydrate intake might help.

Because there's not much clear information from big studies about diet and BAD, a new eating plan called 'The 8x5 Diet' has been created. This plan is based on the latest research into how food choices can impact gut health. Before we can do a really big study to prove if this diet works, we need to do a smaller, introductory study like this one. This helps us iron out any difficulties and make sure a larger study would run smoothly.

This study will recruit 76 adults across the UK who have BAD and are still experiencing diarrhoea, without other serious health problems. Half will continue with their usual diet, and the other half will follow The 8x5 Diet with guidance from a specialist dietitian. We'll be looking to see how easy it is to recruit people, whether they stay in the study, and if they find the diet manageable. This information is vital to help us design a bigger, more thorough study in the future to see if The 8x5 Diet can truly improve symptoms for people with BAD.

Key takeaways

A UK-wide study for adults with ongoing Bile Acid Diarrhoea (BAD).
Compares usual diet with a new plan: 'The 8x5 Diet'.
Aims to check if a larger study on this diet is doable.
Participation is online, no physical clinic visits needed.
If in the diet group, you'll get dietitian support.
Not testing if the diet cures BAD, but how practical it is to study.

Who may be eligible?

This study is open to adults aged 18 or over who live in the UK and have a diagnosed condition called Bile Acid Diarrhoea (BAD). You should have been told by a doctor that you have BAD, and this diagnosis needs to have been confirmed by a specific test called a 7-day SeHCAT scan. It's important that you are still experiencing ongoing diarrhoea despite taking your usual medicines for BAD.

You also need to be able to talk in English and use a computer, laptop, smartphone, or tablet to take part. Your body mass index (BMI) should be 20 or above. You must be able to give your informed consent in writing, which means you understand what the study involves and agree to take part. Finally, we'll need your GP's address so we can let them know you’re participating.

There are some reasons why you wouldn't be able to join. These include if you're pregnant, breastfeeding, or planning to get pregnant soon. You can't take part if you have other serious gut conditions like Inflammatory Bowel Disease or microscopic colitis, or other major health problems such as liver or pancreatic disease. If your diarrhoea isn't very active (less than 3 stools per day or less than 1 watery stool per day), or if you're already in another study or have been in one very recently, you wouldn't be eligible. Certain medications like insulin, some metformin, or weight loss drugs, or recent antibiotic use, would also exclude you. We also can't include you if you have food allergies (other than hayfever-related ones) or if you are already on a strict special diet (like gluten-free due to coeliac disease) that would clash with the study diet.

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 18 or over and live in the UK?
Have you been diagnosed with Bile Acid Diarrhoea (BAD) confirmed by a SeHCAT test?
Are you still experiencing ongoing diarrhoea despite your usual BAD medication?
Can you use a computer/smartphone and speak English?
Are you not pregnant, breastfeeding, or planning a pregnancy soon?
Do you *not* have other serious gut conditions or major illnesses?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for 8 weeks and will be conducted entirely online, so you won't need to visit a clinic in person. After agreeing to take part and providing your consent, you'll be randomly put into one of two groups. One group will continue eating their usual diet, and the other group will follow 'The 8x5 Diet'. If you're in the diet group, you'll receive detailed advice and support from a specialist dietitian. We expect you to stick to the group you're assigned to for the full eight weeks. Throughout the study, you'll be asked to provide information about your symptoms and diet. The main part of the study measures how practical it is to recruit and manage participants, rather than directly testing the diet's effectiveness at this stage. There are no study medications involved.

Potential risks and benefits

Participating in this study might offer you the potential benefit of learning more about managing your Bile Acid Diarrhoea, especially if you're assigned to The 8x5 Diet group and receive support from a dietitian. However, as this is a feasibility study, the direct clinical benefits for you are not the primary goal, and we can't guarantee your symptoms will improve. Potential risks could include the inconvenience of carefully following a new diet or tracking your symptoms. As with any diet change, there's always a small chance of minor digestive upset or not liking the food choices. However, the diet has been designed to be healthy. Your involvement is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

Yvonne McKenzie
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is Bile Acid Diarrhoea (BAD)?

It's a condition where too much bile acid reaches your large bowel, causing frequent, watery, and often urgent diarrhoea. It's not uncommon and can be very disruptive.

What is 'The 8x5 Diet'?

It's a healthy eating plan specially developed for people with Bile Acid Diarrhoea, based on research into how certain foods might affect symptoms. This study will explore how practical it is for people to use.

Will I have to pay to take part or for the diet?

No, you will not have to pay to take part. The study will cover the costs associated with the dietitian support and study materials.

What if my symptoms get worse during the study?

You should always consult your own doctor if you have concerns about your health or if your symptoms worsen. You can also withdraw from the study at any time.

Why is this study being done if it's not directly testing if the diet works?

This 'feasibility' study helps us test if a bigger, future study to prove if the diet works is possible and how to best run it. It's a crucial first step in research.

How to find out more

Yvonne McKenzie, MSc

yvonne.mckenzie@postgrad.manchester.ac.uk 07966878758 Official trial record

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