Exploring the effects of a special diet on patients with axial spondyloarthritis
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis
This study is testing if a special diet can help people with active axial spondyloarthritis feel better by improving their gut health and reducing inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (Glasgow and 1 other locations) |
| Trial ID | NCT06460805 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a Partial Enteral Nutrition (PEN) diet on patients with active axial spondyloarthritis (axSpA), a condition often associated with intestinal inflammation and microbiome dysbiosis. Participants will follow a 2-week PEN diet, which includes a liquid formula and some solid foods, to assess its effects on gut health and systemic inflammation markers. A control group of healthy volunteers will also follow the same diet for comparison. The goal is to determine if this dietary approach can improve symptoms and overall health in axSpA patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older with a diagnosis of active axial spondyloarthritis and a BASDAI score of 4 or higher.
Not a fit: Patients with a prior diagnosis of inflammatory bowel disease or those currently on certain treatments or with specific dietary restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve symptoms and gut health in patients with axial spondyloarthritis.
How similar studies have performed: While similar dietary interventions have shown promise in inflammatory bowel disease, this specific approach in axSpA is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Glasgow and 1 other locations
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Recruiting)
- University of Glasgow — Glasgow, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Stefan Siebert
- Email: stefan.siebert@glasgow.ac.uk
- Phone: 00441413303375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.