At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Partial enteral nutrition (supplement)
- How long the study runs
- Study runs about 16 months (dates as stated)
- About the drug or intervention
- Partial enteral nutrition — supplement: 70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 62
- Started
- 2024-04-25
- Last checked
- 2024-06
Plain English Summary
What is this study?
- • Testing a new treatment for axial spondyloarthritis
- • NA - 62 participants
- • 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
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with axial spondyloarthritis
Where?
- • Glasgow - NHS Greater Glasgow and Clyde
- • Glasgow - University of Glasgow
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓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
- ✓Age ≥ 16 years
See the full criteria
Where Is This Study? (2 UK sites)
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
University of Glasgow
Glasgow, United Kingdom
How to Get in Touch
Stefan Siebert
Sponsor contactCONTACT
