NCT05289011

Brief Summary

The food composition and consumption of certain foods could be associated with a higher or lower inflammatory activity of spondyloarthritis and consequently changes in the quality of life of patients. This has been shown in other chronic inflammatory disease. In order to highlight a profile or nutritional profiles associated with the activity of the disease, we chose to carry out observational pilot study using a qualitative food survey, which will be submitted to all patients with spondyloarthritis. The general demographic data and the data of the disease will be collected by the investigating physician at the same time, as well as possible confounding factors: comorbidities, physical activity, treatments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
Last Updated

March 21, 2022

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

March 9, 2022

Last Update Submit

March 18, 2022

Conditions

Keywords

SpondyloarthrosisNutrition Disorders

Outcome Measures

Primary Outcomes (2)

  • Nutritional survey

    internal questionnaire, correlation between patient's nutrition profile and disease activity

    Day 0

  • Disease activity

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), score ASDAS, correlation between patient's nutrition profile and disease's activity

    Day 0

Secondary Outcomes (4)

  • Physical activity

    Day 0

  • Assess the quality of life

    Day 0

  • Digestive symptoms

    Day 0

  • Fatigue

    Day 0

Study Arms (1)

Patients with spondyloarthritis without Inflammatory bowel disease

Other: Interviews and questionnaires

Interventions

* Evaluation of inflammatory rheumatism * Dietary survey * International Physical Activity Questionnaire IPAQ * BASDAI self-questionnaire * Assessment of quality of life by ASQol questionnaire * Assessment of fatigue by FACIT questionnaire * Assessment of digestive symptoms * Collection of demographic and general data * Collection of treatment

Patients with spondyloarthritis without Inflammatory bowel disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with axial or peripheral spondyloarthritis

You may qualify if:

  • Patients over the age of 18 who meet the ASAS criteria for axial or peripheral spondyloarthritis
  • Patients agreeing to participate and not objecting to the use of their personal data

You may not qualify if:

  • Presence of Inflammatory bowel disease: Crohn's or RCH diagnosed
  • History of bariatric surgery
  • Patient subject to a court order, guardianship or trusteeship
  • Patient unable to complete questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges University Hospital

Limoges, 87000, France

Location

MeSH Terms

Conditions

SpondylarthritisNutrition Disorders

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 21, 2022

Study Start

February 13, 2018

Primary Completion

February 3, 2020

Study Completion

February 3, 2020

Last Updated

March 21, 2022

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations