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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

• 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.

• Age ≥ 16 years

• Current student and/or staff member at the University of Glasgow

• Willing and able to give informed written consent

Locations
Other Locations
United Kingdom
NHS Greater Glasgow and Clyde
RECRUITING
Glasgow
University of Glasgow
RECRUITING
Glasgow
Contact Information
Primary
Stefan Siebert
stefan.siebert@glasgow.ac.uk
00441413303375
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 62
Treatments
Experimental: Axial Spondyloarthritis
Experimental: Healthy Volunteers
Sponsors
Collaborators: University of Glasgow
Leads: NHS Greater Glasgow and Clyde

This content was sourced from clinicaltrials.gov