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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorNHS Greater Glasgow and Clyde

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Partial enteral nutrition

    Dietary supplement

    70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Axial SpondyloarthritisExperimental treatment 1 intervention
Group B: Healthy VolunteersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in faecal butyrate at 2 weeks on a PEN diet

Time frame
2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Glasgow

Collaborator