Spondyloarthritis and Nutrition (SANUT)

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.

Study Overview

• Status: Completed
• Conditions: Nutrition Disorders; Spondyloarthrosis
• Intervention / Treatment: Other: Interviews and questionnaires

• Study Type: Observational
• Enrollment (Actual): 382

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87000
    • Limoges University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with axial or peripheral spondyloarthritis

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with spondyloarthritis without Inflammatory bowel disease	Other: Interviews and questionnaires; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity	International Physical Activity Questionnaire (IPAQ)	Day 0
Assess the quality of life	Ankylosing Spondylitis Quality of Life Questionnaire (ASQol)	Day 0
Digestive symptoms	Internal questionnaire, correlation between patient's nutrition profile and digestive symptoms The digestive symptom questionnaire had 6 questions, one for each symptom: constipation or hard stools, diarrhoea or frequent stools, stomach pains, gastroesophageal reflux or pyrosis, abdominal pain, and bloating. Each question was scored between 0 to 4: 0 (never occurred), 1 (rarely), 2 (sometimes), 3 (most of the time), and 4 (always). Thus, the cumulative score ranged from 0 to 24	Day 0
Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) instrument. The FACIT-F instrument has 13 items with a score ranging from 0 to 52: lower scores indicating more fatigue	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2018
• Primary Completion (ACTUAL): February 3, 2020
• Study Completion (ACTUAL): February 3, 2020

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 18, 2022
• First Posted (ACTUAL): March 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Nutrition Disorders; Spondyloarthrosis
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Nutrition Disorders; Spondylitis; Spondylarthritis; Spondylarthropathies
• Other Study ID Numbers: I17008 (SANUT)

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