Spondyloarthritis and Nutrition

Nutrition Disorders Clinical Trial

— SANUT  

Official title:

Spondyloarthritis and Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289011
• Other study ID #: I17008 (SANUT)
• Status: Completed
• Start date: February 13, 2018
• Est. completion date: February 3, 2020

Study information

• Verified date: February 2020
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: February 3, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Disorders
• Spondylarthritis
• Spondylarthropathies
• Spondyloarthrosis

Intervention

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

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional survey	internal questionnaire, correlation between patient's nutrition profile and disease activity	Day 0
Primary	Disease activity	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), score ASDAS, correlation between patient's nutrition profile and disease's activity	Day 0
Secondary	Physical activity	International Physical Activity Questionnaire (IPAQ)	Day 0
Secondary	Assess the quality of life	Ankylosing Spondylitis Quality of Life Questionnaire (ASQol)	Day 0
Secondary	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
Secondary	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