RecruitingNAINTERVENTIONAL

Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis

This study aims to discover if a higher-fibre diet can improve the health of the gut and reduce symptoms for adults living with rheumatoid arthritis (RA). Researchers believe that increasing fibre intake might help beneficial gut bacteria produce helpful substances, which could then ease RA. They also want to see if it helps with weight loss, which is often good for RA patients. The study will involve two groups: one will get advice on eating more fibre and take psyllium husks daily, while the other will stick to their usual diet. Participants will provide stool samples, have their arthritis checked, and their weight monitored over 12 months. This could offer new ways to manage RA alongside existing treatments.

At a glance

Status

Recruiting

Phase

Sponsor

Wuerzburg University Hospital

Enrolment target

Start

01 Jun 2024

Estimated completion

30 Dec 2026

Arthritis, Rheumatoid

What is this study about?

This study is looking into how our diet, especially how much fibre we eat, might affect rheumatoid arthritis (RA). RA is a condition where the body's own immune system attacks its joints, causing pain and swelling. Recent research has shown that the tiny organisms living in our gut, known as the 'gut microbiome', play a big part in how our immune system works. It's thought that these gut bugs might even influence how RA develops and progresses. When we eat fibre, our gut bacteria produce helpful substances called short-chain fatty acids (SCFAs), which are believed to have a positive effect on our immune system and could potentially help with RA.

Many of us in the UK don't get enough fibre in our diets. This study wants to find out if simply increasing the amount of fibre someone eats can make a real difference for people with RA. They are hoping to see if a high-fibre diet can improve the balance of good bacteria in the gut, boost those helpful SCFAs, and in turn, make RA symptoms less severe. Another benefit researchers are keen to explore is whether more fibre can help with weight management, as being a healthy weight is often beneficial for people with RA.

Essentially, the study aims to answer two key questions: Can a fibre-rich diet improve your gut health by changing your gut bacteria and boosting beneficial chemicals? And does this then lead to fewer RA symptoms and help with weight loss? By understanding this better, we could discover new and simple dietary approaches to help manage RA alongside current medical treatments.

Key takeaways

Looks at how a high-fibre diet impacts rheumatoid arthritis.
Aims to improve gut health and reduce RA symptoms.
Involves taking psyllium husks daily for one group.
Monitors gut bacteria, RA activity, and body weight.
Lasts for 12 months with regular check-ups.
Could help find new ways to manage RA through diet.

Who may be eligible?

To be part of this study, you need to be an adult over 18 years old and have been diagnosed with rheumatoid arthritis using the widely recognised ACR criteria from 2010. It's also important that you can understand what the study involves and are happy to give your written permission to take part.

There are certain reasons why someone might not be able to join. For example, if you are under 18, or if you have certain other serious health conditions like inflammatory bowel disease (like Crohn's or ulcerative colitis), severe liver problems, or a history of bowel blockages. Also, if you've recently taken antibiotics (within the last three months) or have been using psyllium husks (within four weeks of starting the study), you wouldn't be able to participate, as these could affect the 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 18 years old or older?
Have you been diagnosed with rheumatoid arthritis?
Can you understand the study information and provide written consent?
Have you *not* taken antibiotics in the last three months?
Have you *not* used psyllium husks in the last four weeks?
Do you *not* have inflammatory bowel disease or severe liver problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly placed into one of two groups. One group will receive advice on how to eat more fibre and will take 10 grams (about two teaspoons) of psyllium husks every day. The other group will simply continue eating their usual diet. The study will last for 12 months.

Throughout the study, you will have various check-ups. You'll fill out surveys about your diet at the start, after 6 months, and again at 12 months. You'll also be asked to provide stool samples so the researchers can study your gut bacteria and the helpful chemicals they produce. Your rheumatoid arthritis activity, such as pain and swelling, will be regularly checked, and your body weight will be monitored. To help you stick to any dietary changes, you'll also receive regular phone calls from the study team. This way, researchers can see how the fibre affects your gut and your RA symptoms over a year.

Potential risks and benefits

Taking part in this study might offer several potential benefits. If the high-fibre diet proves effective, you could experience improved gut health, fewer rheumatoid arthritis symptoms, and potentially help with weight management. However, there's no guarantee you'll personally benefit, and some people might experience mild digestive changes like increased wind or bloating when first increasing fibre intake. As with any study, there are no medical recommendations, and you are free to leave the study at any time without giving a reason, which would not affect your routine medical care.

Locations (1)

University Würzburg
Verified postcode
Würzburg, Germany· Recruiting

Common questions

What are psyllium husks?

Psyllium husks are a type of fibre made from the seeds of a plant. They absorb water and can help make your gut healthier.

What is the 'gut microbiome'?

This is the collection of trillions of tiny living organisms, mainly bacteria, that live in your intestines. They play a big role in your health.

How long will the study last?

The study will last for 12 months, which is one year.

Will I have to change my medicines for RA?

The study doesn't ask you to change your current RA medicines. It's looking at if diet can help alongside your usual treatment.

What are 'short-chain fatty acids' (SCFAs)?

These are helpful chemicals produced by your gut bacteria when they digest fibre. They are thought to be good for your immune system.

How to find out more

Eva C Schwaneck, M.D.

e.schwaneck@rheuma-hh.de +49 40 1818 81 8343 Official trial record

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