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

June 13, 2024 updated by: NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Recruiting
        • NHS Greater Glasgow and Clyde
        • Contact:
        • Principal Investigator:
          • Stefan Siebert
      • Glasgow, United Kingdom
        • Recruiting
        • University of Glasgow
        • Sub-Investigator:
          • Simon Milling
        • Contact:
        • Principal Investigator:
          • Stefan Siebert
        • Sub-Investigator:
          • Rumaisa Zubairi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Volunteers
Dietary supplement: Partial enteral nutrition
70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods
Other Names:
  • PEN
Experimental: Axial Spondyloarthritis
Dietary supplement: Partial enteral nutrition
70% caloric intake from enteral nutrition formula and 30% caloric intake from a limited range of solid foods
Other Names:
  • PEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in faecal butyrate at 2 weeks on a PEN diet
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN23RH450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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