Actively Recruiting
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis
Led by NHS Greater Glasgow and Clyde · Updated on 2024-06-14
62
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NHS Greater Glasgow and Clyde
Lead Sponsor
U
University of Glasgow
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with axial spondyloarthritis (axSpA) often experience intestinal inflammation and imbalances in their gut microbiome, similar to Crohn's-like inflammatory bowel disease. Researchers are investigating whether a Partial Enteral Nutrition (PEN) diet, which includes a liquid formula and some solid foods and is known to help induce remission in IBD, can affect the gut microbiome and intestinal inflammation in axSpA patients and whether these changes influence systemic inflammation. The study involves a 2-week course of the PEN diet, with an optional additional 2-week extension, in people with active axSpA. The diet provides 70% of calories from an enteral nutrition formula and 30% from a limited range of solid foods. A group of healthy volunteers will also follow the same diet to serve as controls. Participants will be monitored for changes in their stool butyrate levels after 2 weeks on the PEN diet, which is the primary outcome. The study includes assessments of gut and immune responses in both axSpA patients and healthy volunteers. Participants will need to provide informed consent and follow the dietary intervention during the study period, with monitoring for adherence and any effects.
CONDITIONS
Brief Title
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of axial spondyloarthritis meeting ASAS criteria
- Active disease with BASDAI score 4 or higher on study visit day
- Stable treatment: no major therapy changes in past 3 months and no dosage adjustments in past 1 month
- Age 16 years or older
- Willing and able to provide informed written consent
- Healthy volunteers must be 16 years or older and current student or staff at University of Glasgow
- Healthy volunteers willing and able to provide informed consent
You will not qualify if you...
- Pregnancy or breastfeeding
- Prior diagnosis of inflammatory bowel disease (IBD) or immune-mediated inflammatory condition for healthy volunteers
- Receipt of chemotherapy, immunotherapy, or radiotherapy in past 3 months
- Recent systemic antibiotic use within last 1 month
- Current eating disorder
- Food allergy incompatible with the diet, such as cow's milk allergy
- Following a vegan diet
- Major surgery in past 3 months or planned within next 3 months
- Unable or unwilling to provide informed consent
- Unable or unwilling to follow the Partial Enteral Nutrition diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants follow a partial enteral nutrition diet consisting of 70% caloric intake from an enteral nutrition formula and 30% from a limited range of solid foods.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 2 locations
1
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Actively Recruiting
2
University of Glasgow
Glasgow, United Kingdom
Actively Recruiting
Research Team
S
Stefan Siebert
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here