axSEND: exploring immune and microbiota effects of a PEN diet in axSpA
Research type
Research Study
Full title
axSEND: exploring immune and microbiota effects of a partial enteral nutrition diet in people with axial spondyloarthritis
IRAS ID
325659
Contact name
Stefan Siebert
Contact email
Sponsor organisation
University of Glasgow
Duration of Study in the UK
1 years, 7 months, 1 days
Research summary
Axial spondylarthritis (axSpA) is a chronic inflammatory condition that mainly affects the spine. There are many small microbes (bacteria) that live in the guts of all people – this is normal. Studies have shown that people with axSpA have different gut microbe populations to people without axSpA. Studies have also shown that people with axSpA can often have mild inflammation in their gut, although they might not have any symptoms from this. We know that gut microbes and inflammation can be affected by diet, so we want to see what effects a diet that has been shown to help bowel inflammation in another condition called Crohn’s disease has on the gut microbes and blood inflammation levels in people with axSpA. This diet is called partial enteral nutrition (PEN) and involves consuming a liquid diet made up of a special liquid fibre-, lactose- and gluten-free formula, and a limited range of solid foods. We will measure this using poo (for gut germs) and blood (for immune cells and inflammatory biomarkers) samples from participants with axSpA before and after the PEN diet.
We aim to recruit 31 adults with axSpA. A further 31 volunteers without axSpA will act as healthy controls. We will provide the PEN diet which we will ask participants to take for for 2 weeks. At the end of the 2 weeks, we will collect another blood and stool sample and offer participants the option to continue the diet for a further 2 weeks, if they wish. If participants choose to do this, we will collect a stool and blood sample at the end of these 4 weeks on the diet. Finally, we will ask for stool and blood samples 4 weeks after the diet ends. Overall, a maximum of 4 blood and stool samples will be collected. We will also collect information relevant to the condition and diet to allow us to understand the results of the samples
REC name
East of Scotland Research Ethics Service REC 1
REC reference
23/ES/0044
Date of REC Opinion
5 Jan 2024
REC opinion
Further Information Favourable Opinion