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Completed

NCT Number: NCT05289011

Spondyloarthritis and Nutrition

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.

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Key information

Conditions

Spondyloarthrosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Limoges University Hospital

Limoges, 87000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interviews and questionnaires

Other
  • 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

Primary outcomes

  1. Nutritional survey

    Time frame: Day 0

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

  2. Disease activity

    Time frame: Day 0

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

Secondary outcomes

  1. Physical activity

    Time frame: Day 0

    International Physical Activity Questionnaire (IPAQ)

  2. Assess the quality of life

    Time frame: Day 0

    Ankylosing Spondylitis Quality of Life Questionnaire (ASQol)

  3. Digestive symptoms

    Time frame: Day 0

    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

  4. Fatigue

    Time frame: Day 0

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: SANUT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2022
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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