Actively Recruiting
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
Led by NHS Greater Glasgow and Clyde · Updated on 2024-06-14
62
Participants Needed
2
Research Sites
66 weeks
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 have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients. In this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.
CONDITIONS
Official 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 of 4 or higher on study visit day
- Stable treatment for at least 3 months with no major changes and no dosage adjustments in the last month
- Age 16 years or older
- Ability and willingness to provide informed written consent
- For healthy volunteers: age 16 years or older, current student or staff at University of Glasgow, and able to 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
- Chemotherapy, immunotherapy, or radiotherapy within the last 3 months
- Use of systemic antibiotics in the past month
- Current eating disorder
- Food allergies incompatible with the study diet, such as cow's milk allergy
- Following a vegan diet
- Major surgery in the past 3 months or planned within the next 3 months
- Inability or unwillingness to provide informed consent or to try the PEN diet
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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