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UNKNOWNNA

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

Sponsor: NHS Greater Glasgow and Clyde

NCT ID: NCT06460805

View on ClinicalTrials.gov ↗

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.

Axial SpondyloarthritisAnkylosing SpondylitisInflammationDysbiosisArthritisSpondylitisSpondylarthritisSpAAxSpA

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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
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 * 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. Exclusion. Participants will have NONE of the following: * 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. Eligibility Criteria for Healthy Volunteer Participants Inclusion criteria. Participants will fulfil ALL of the following: * Age ≥ 16 years * Current student and/or staff member at the University of Glasgow * Willing and able to give informed written consent Exclusion. Participants will have NONE of the following: * Pregnancy or breastfeeding * Prior diagnosis of an immune-mediated inflammatory condition * 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.

Where Is This Study? (2 UK sites)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Stefan SiebertPrincipal Investigator

University of Glasgow

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Stefan SiebertPrincipal Investigator

How to Get in Touch

Stefan Siebert

Sponsor contact

CONTACT

00441413303375 stefan.siebert@glasgow.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-06