SpondyloarthrosisSANUTNCT05289011
Spondyloarthritis and Nutrition
An observational study of Spondyloarthrosis and Nutrition Disorders, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthrosis, Nutrition Disorders
- What is being tested?
- Interviews and questionnaires
- How many people
- 382 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 3 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with axial or peripheral spondyloarthritis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spondyloarthrosis, Nutrition Disorders
- Being tested
- Interviews and questionnaires
- Keywords
- Spondyloarthrosis, Nutrition Disorders
- Medical subject headings
- Spondylarthritis, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews and questionnairesOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with spondyloarthritis without Inflammatory bowel disease | Not described Receives: Other: Interviews and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional survey
internal questionnaire, correlation between patient's nutrition profile and disease activity
Measured: Day 0
Disease activity
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), score ASDAS, correlation between patient's nutrition profile and disease's activity
Measured: Day 0
Secondary outcomes (4)
Physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: Day 0
Assess the quality of life
Ankylosing Spondylitis Quality of Life Questionnaire (ASQol)
Measured: 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
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start13 Feb 2018
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289011
- Sponsor's protocol ID
- I17008 (SANUT)
- Acronym
- SANUT
- Status last verified
- Feb 2020
- First submitted
- 9 Mar 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spondyloarthritis and Nutrition
- ClinicalTrials.gov ID
- NCT05289011
- Acronym / sponsor ID
- SANUT / I17008 (SANUT)
- Conditions
- Spondyloarthrosis, Nutrition Disorders
- Keywords
- Spondyloarthrosis, Nutrition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with spondyloarthritis without Inflammatory bowel disease | – | Other: Interviews and questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with axial or peripheral spondyloarthritis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Patients with spondyloarthritis without Inflammatory bowel disease |
Primary outcome
Nutritional survey
Time frame: Day 0
internal questionnaire, correlation between patient's nutrition profile and disease activity
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
4 secondary outcomes
Physical activity
Time frame: Day 0
Assess the quality of life
Time frame: Day 0
Digestive symptoms
Time frame: Day 0
Fatigue
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthrosis and Nutrition Disorders, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional survey (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.