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

Inflammation Clinical Trial

— axSEND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460805
• Other study ID #: GN23RH450
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: June 2024
• Source: NHS Greater Glasgow and Clyde
• Contact: Stefan Siebert
• Phone: 00441413303375
• Email: stefan.siebert[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Axial Spondyloarthritis
• Dysbiosis
• Inflammation
• SpA
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Dietary Supplement:
• Partial enteral nutrition
70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	University of Glasgow	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in faecal butyrate at 2 weeks on a PEN diet		2 weeks