Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460805
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-05
Brief Title:
axSEND Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
axSEND Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
axSEND
Brief Summary:
People with axial spondyloarthritis axSpA often have intestinal inflammation and intestinal microbiome dysbiosis with some similarities to Crohns-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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None