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

Launched by NHS GREATER GLASGOW AND CLYDE · Jun 13, 2024

Keywords

ClinConnect Summary

The axSEND clinical trial is investigating the effects of a special diet called Partial Enteral Nutrition (PEN) on individuals with axial spondyloarthritis (axSpA), a condition that causes inflammation in the spine and other areas. This diet includes a mix of liquid nutrition and some solid foods, and researchers want to see if it can help improve gut health and reduce inflammation in patients with active axSpA. The study will involve participants following the PEN diet for two weeks, with the option to extend for another two weeks, while a group of healthy volunteers will follow the same diet for comparison.

To be eligible for this trial, participants must be at least 16 years old, have a confirmed diagnosis of axSpA, and show signs of active disease. They should also be stable on their current treatment for at least one month. Importantly, individuals who are pregnant, have certain health conditions like inflammatory bowel disease, or follow a vegan diet cannot participate. Throughout the trial, participants will be carefully monitored to understand the diet's impact on their condition. This study aims to provide valuable insights into how dietary changes can affect inflammation and gut health in people with axSpA.

Gender

ALL

Eligibility criteria

• • Eligibility Criteria for Participants with axSpA
• Inclusion criteria. Participants will fulfil ALL of the following:
• • Diagnosis of axSpA (fulfilling the ASAS criteria)
• • Active disease (BASDAI score ≥4) on day of study visit
• • Stable on treatment \[defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month\]
• • Age ≥ 16 years
• • Willing and able to give informed written consent.
• Exclusion. Participants will have NONE of the following:
• • Pregnancy or breastfeeding
• • Prior diagnosis of IBD
• • Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months
• • Recent systemic antibiotic use (within last 1 month)
• • Current eating disorder
• • Food allergy incompatible with diet (e.g. cow's milk allergy)
• • Following a vegan diet
• • Major surgery in prior 3 months or planned in forthcoming 3 months.
• • Unable or unwilling to give informed consent
• • Unable or unwilling to try the PEN diet.
• • Eligibility Criteria for Healthy Volunteer Participants
• Inclusion criteria. Participants will fulfil ALL of the following:
• • Age ≥ 16 years
• • Current student and/or staff member at the University of Glasgow
• • Willing and able to give informed written consent
• Exclusion. Participants will have NONE of the following:
• • Pregnancy or breastfeeding
• • Prior diagnosis of an immune-mediated inflammatory condition
• • Recipient of chemotherapy/immunotherapy/radiotherapy in prior 3 months
• • Recent systemic antibiotic use (within last 1 month)
• • Current eating disorder
• • Food allergy incompatible with diet (e.g. cow's milk allergy)
• • Following a vegan diet
• • Major surgery in prior 3 months or planned in forthcoming 3 months.
• • Unable or unwilling to give informed consent
• • Unable or unwilling to try the PEN diet.