Axial SpondyloarthritisaxSENDNCT06460805
axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis
A study testing Partial enteral nutrition in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Axial Spondyloarthritis, Ankylosing Spondylitis, Inflammation
- What is being tested?
- Partial enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 25 Apr 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 25Show fewer
- 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
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow
Stefan Siebert, 00441413303375, stefan.siebert@glasgow.ac.uk
Stefan Siebert
- Recruiting
University of Glasgow
Glasgow
Stefan Siebert, 00441413303375, stefan.siebert@glasgow.ac.uk
Stefan Siebert
About this study
Official title: axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis
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.
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis, Inflammation, Dysbiosis, Arthritis, Spondylitis
- Being tested
- Partial enteral nutrition
- Keywords
- Partial Enteral Nutrition, Nutrition, Axial spondyloarthritis, Ankylosing spondylitis, axSpA, Diet, PEN, AS
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Inflammation, Dysbiosis, Arthritis, Spondylitis, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial enteral nutritionDietary supplement
Also called PEN
70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods
| Study group | Role | What they receive |
|---|---|---|
| Axial Spondyloarthritis | Experimental | Not described Receives: Dietary Supplement: Partial enteral nutrition |
| Healthy Volunteers | Experimental | Not described Receives: Dietary Supplement: Partial enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal butyrate at 2 weeks on a PEN diet
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start25 Apr 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460805
- Sponsor's protocol ID
- GN23RH450
- Acronym
- axSEND
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06460805
- Acronym / sponsor ID
- axSEND / GN23RH450
- Conditions
- Axial Spondyloarthritis, Ankylosing Spondylitis, Inflammation, Dysbiosis, Arthritis, Spondylitis
- Keywords
- Partial Enteral Nutrition, Nutrition, Axial spondyloarthritis, Ankylosing spondylitis, axSpA, Diet, PEN, AS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial Spondyloarthritis | Experimental | Dietary Supplement: Partial enteral nutrition |
| Healthy Volunteers | Experimental | Dietary Supplement: Partial enteral nutrition |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial enteral nutritionAlso: PEN70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods | Dietary supplement | Axial Spondyloarthritis, Healthy Volunteers |
Primary outcome
Change in faecal butyrate at 2 weeks on a PEN diet
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial enteral nutrition in people with Axial Spondyloarthritis and Ankylosing Spondylitis, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Siebert (00441413303375, stefan.siebert@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in faecal butyrate at 2 weeks on a PEN diet (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.