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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Axial Spondyloarthritis Ankylosing Spondylitis Inflammation Dysbiosis Arthritis Spondylitis Spondylarthritis SpA AxSpA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Axial Spondyloarthritis

Group Type EXPERIMENTAL

Partial enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

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

Healthy Volunteers

Group Type EXPERIMENTAL

Partial enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Partial enteral nutrition

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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PEN

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes