Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT06460805
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06460805
Study Brief:
Protocol Section:
NCT06460805