RecruitingNAINTERVENTIONAL

axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis

This study, called axSEND, is exploring a special diet for people with axial spondyloarthritis (axSpA), including conditions like ankylosing spondylitis. Many people with axSpA have gut inflammation and an imbalance of gut bacteria (dysbiosis), similar to what's seen in Crohn's disease. We know that a diet called Partial Enteral Nutrition (PEN), which involves liquid formulas and some solid food, can help people with inflammatory bowel disease. This research aims to see if PEN can also improve the gut bacteria and reduce inflammation in people with axSpA, and if these changes are linked to reduced inflammation throughout the body. The study will involve a 2-week diet with an optional extension for people with active axSpA, comparing them to healthy volunteers following the same diet.

At a glance

Status

Recruiting

Phase

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

Start

25 Apr 2024

Estimated completion

01 Aug 2025

Axial Spondyloarthritis Ankylosing Spondylitis Inflammation Dysbiosis Arthritis Spondylitis Spondylarthritis SpA AxSpA

What is this study about?

This study, named axSEND, is focused on a condition called axial spondyloarthritis (axSpA), which includes ankylosing spondylitis. People with axSpA often experience pain, stiffness, and fatigue, primarily affecting the spine and large joints. Interestingly, many individuals with axSpA also have inflammation in their gut and an imbalance of gut bacteria, known as dysbiosis. This gut picture shares some similarities with inflammatory bowel diseases (IBD), such as Crohn's disease.

Researchers are particularly interested in a specific type of diet called Partial Enteral Nutrition (PEN). This diet involves consuming a liquid formula for most of your meals, along with a limited amount of regular solid foods. PEN has been shown to be very effective in helping people with IBD go into remission. However, it's not yet known if this diet could have similar benefits for people with axSpA, specifically by helping to rebalance their gut bacteria, reduce gut inflammation, and potentially lower overall body inflammation.

The main goal of this study is to investigate these very questions. Participants with active axSpA will follow the PEN diet for two weeks, with the option to continue for another two weeks. There will also be a group of healthy volunteers who will follow the same diet to help researchers understand the effects better. By looking at how the diet changes gut bacteria and markers of inflammation in the body, the study hopes to shed light on new ways to potentially manage axSpA.

Key takeaways

This study explores a special diet for axial spondyloarthritis (axSpA).
It investigates if a liquid-plus-food diet (PEN) can improve gut health and inflammation.
The study includes people with active axSpA and healthy volunteers.
Participation involves following a specific diet for 2-4 weeks.
Researchers will monitor gut bacteria and inflammation markers.
You must be 16+ and on stable axSpA treatment to participate.

Who may be eligible?

This study is looking for two main groups of people: individuals with axial spondyloarthritis (axSpA) and healthy volunteers.

If you have axSpA, you would need to be diagnosed with the condition (meeting specific criteria), have active symptoms (a BASDAI score of 4 or higher), and have been on a stable treatment plan for your condition (no major changes in the last 3 months, or minor changes in the last month). You must be 16 years or older and willing to try the study diet.

You cannot take part if you are pregnant or breastfeeding, have a history of inflammatory bowel disease, have had chemotherapy, immunotherapy, or radiotherapy recently (within 3 months), used antibiotics in the last month, have an eating disorder, or have food allergies (like cow's milk) that prevent you from following the diet. People who are vegan, have had major surgery recently, or have one planned soon, also cannot join. Healthy volunteers must be 16 or older, a student or staff member at the University of Glasgow, and generally meet similar exclusion criteria to avoid interfering with the study results.

Quick self-check

Do I have a diagnosis of axial spondyloarthritis (axSpA)?
Are my axSpA symptoms currently active (BASDAI score of 4 or higher)?
Have I been on a stable treatment for my axSpA for at least the last 3 months?
Am I 16 years old or older?
Am I willing and able to try a special liquid and limited food diet?
Am I NOT pregnant or breastfeeding, and have I NOT had recent major surgery or certain medical treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will follow a Partial Enteral Nutrition (PEN) diet for two weeks, with the option to extend it for another two weeks. This diet involves drinking a special liquid formula for most of your meals, complemented by a small amount of carefully selected solid foods. Researchers will regularly check in with you and conduct assessments to monitor how your body and gut are responding to the diet. This might involve providing stool samples to look at your gut bacteria, and blood tests to measure your inflammation levels. There are no specific medications involved in the study beyond what you are already taking for your axSpA (which should be stable). The total duration of your active participation, including the optional extension, would be up to four weeks, followed by further check-ups to see if any changes are long-lasting.

Potential risks and benefits

Taking part in this study could offer potential benefits, such as a better understanding of your condition and whether a diet like PEN might be helpful for managing your symptoms or improving your gut health. However, as with any research study, there are potential risks. The PEN diet can be restrictive and may be challenging to follow. You might experience some minor side effects related to changes in your diet, and there's always a small risk associated with blood tests. While we hope for positive outcomes, there's no guarantee that the diet will improve your axSpA. Your well-being is paramount, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

NHS Greater Glasgow and Clyde
Glasgow, United Kingdom· Recruiting
University of Glasgow
Glasgow, United Kingdom· Recruiting

Common questions

What is 'Partial Enteral Nutrition' (PEN)?

It's a special diet where you mainly drink a liquid formula for your meals, along with a small amount of regular solid foods.

What is axial spondyloarthritis (axSpA)?

It's a type of arthritis that mainly causes long-term pain and stiffness in your spine and sometimes other joints.

Why are you looking at gut bacteria?

Many people with axSpA have an imbalance of gut bacteria and gut inflammation, which might be linked to their condition. We want to see if the diet can improve this.

Will I have to stop my current medication?

No, you need to be on a stable treatment plan for your axSpA and will continue your current medications during the study.

How long will I be on the special diet?

You will be on the diet for two weeks, with the option to continue for another two weeks if you wish.

How to find out more

Stefan Siebert

stefan.siebert@glasgow.ac.uk 00441413303375 Official trial record

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