NCT06460805

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Axial Spondyloarthritis
• Ankylosing Spondylitis
• Inflammation
• Dysbiosis
• Arthritis
• Spondylitis
• Spondylarthritis
• SpA
• AxSpA

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Partial enteral nutrition	70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-06-14
• Last updated: 2024-06-14

Locations

2 sites across 1 country: United Kingdom