axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
axSEND
1 other identifier
interventional
62
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2024
CompletedFirst Submitted
Initial submission to the registry
June 5, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedJune 14, 2024
June 1, 2024
1.3 years
June 5, 2024
June 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in faecal butyrate at 2 weeks on a PEN diet
2 weeks
Study Arms (2)
Axial Spondyloarthritis
EXPERIMENTALHealthy Volunteers
EXPERIMENTALInterventions
70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- University of Glasgowcollaborator
Study Sites (2)
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
University of Glasgow
Glasgow, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2024
First Posted
June 14, 2024
Study Start
April 25, 2024
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
June 14, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share