Ankylosing SpondyloarthritisGlutenSPANCT04274374
Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.
A study testing Gluten-Free Diet and Gluten Diet in people with Ankylosing Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 7 sites in France.
Trial summary
Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondyloarthritis
- What is being tested?
- Gluten-Free Diet and Gluten Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 7 Oct 2021to Mar 2026
- Phase
- Interventional
- 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
Who may be able to join
- diagnosis of axial SpA defined by ASAS criteria
- Rheumatologist not wish to change the treatment within 4 months of inclusion,
- stable treatment (NSAID and/or DMARD) for at least 3 months but no corticosteroid infiltration in the month prior to inclusion,
- able to follow a GFD and to provide written informed consent and submit to the requirements of the study
Who cannot join
- Any diet at the time of inclusion or within 3 months prior to inclusion;
- have a history of celiac disease;
- received antibiotic treatment within 3 months of inclusion or are taking a probiotic;
- are pregnant, breastfeeding,
- not covered by social security;
- minors or adults under the protection of the law or under the protection of justice.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Not yet recruiting
CHU de Bordeaux
Bordeaux, 33000
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Thierry SHAEVERBEKE, MD, PhD
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Marion COUDERC, MD
- Not yet recruiting
CHU de Grenoble
Grenoble, 38000
Lise laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Philippe GAUDIN, MD, PhD
- Not yet recruiting
Hospices Civils de Lyon
Lyon, 69000
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Roland CHAPURLAT, MD, PhD
- Not yet recruiting
CHU de Montpellier
Montpellier, 34000
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Jacques MOREL, MD, PhD
- Not yet recruiting
Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin
Paris, 75000
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Maxime DOUGADOS, MD, PhD
- Not yet recruiting
CHU de Saint-Etienne
Saint-Etienne, 42000
Lise Laclautre, 334.73.754.963, promo_interne_drci@chu-clermontferrand.fr
Thierry THOMAS, MD, PhD
About this study
Official title: Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis: Study Protocol of a Randomized Double-blind Placebo-controlled Trial
Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.
Read the detailed description
The GlutenSpA study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day. The control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day.
At baseline, the dietician will explain to the patients how to properly follow a GFD during a face-to-face interview. The patient's compliance to the GFD will be evaluated by the dietician at S2, S16, an S24 using an online 3-day alimentary questionnaire.
The bread and penne pasta were chosen for their visual resemblance and similar taste to maximize the blindness of the study. In order to reach the daily amount of gluten in a standard diet (estimated in France between 10 and 15 g/d) in the control arm, each day patients will have to ingest six capsules of vital gluten wheat made for the study. Vital gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a base for making products, such as seitan. Capsules will be made using commercially available vital gluten and contain 0.35 g of gluten per capsule. The total amount of gluten in the control arm will be approximately 10.5 g/day.
After the 16-week GFD, patients will be offered to follow or not follow the GFD according to their own decision for an 8-week open-labelled follow-up period. The study duration for each patient is 24 weeks. The patient recruitment is expected to last 2 years
- Conditions
- Ankylosing Spondyloarthritis
- Being tested
- Gluten-Free Diet, Gluten Diet
- Keywords
- spondyloarthritis, ankylosing spondylitis, gluten-free diet, gut microbiota
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten-Free DietDietary supplement
Dietary supplement without gluten
Gluten DietDietary supplement
Dietary supplement with gluten
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | In the experimental arm will receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day Receives: Dietary Supplement: Gluten-Free Diet |
| control arm | Active comparator | the control arm will received 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day Receives: Dietary Supplement: Gluten Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index
The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with SpA. The total sum of the ASAS HI ranges from 0-17, with a lower score indicating a better health status.
Measured: Change from baseline ASAS HI score at 16 weeks
Secondary outcomes (11)
effects of a 16-week GFD versus placebo diet on the activity of SpA evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease,
Measured: Change from baseline BASDAI score at 16 weeks
effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the erythrocyte sedimentation rate (ESR).
An ESR is a type of blood test that measures how quickly erythrocytes settle at the bottom of a test tube that contains a blood sample. Normally, red blood cells settle relatively slowly. A faster-than-normal rate may indicate inflammation in the body.
Measured: Change from baseline ESR at 16 weeks
effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the C-reactive protein (CRP)
A c-reactive protein test measures the level of c-reactive protein (CRP) in your blood. CRP is a protein made by your liver. It's sent into your bloodstream in response to inflammation. Normally, you have low levels of c-reactive protein in your blood. High levels may be sign of a serious infection or other disorder.
Measured: Change from baseline CRP at 16 weeks
effects of a 16-week GFD versus placebo diet on fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
The FACIT Fatigue Scale is a short, 13-item, that measures an individual's level of fatigue during their usual daily activities over the past week. Score range 0-52. A score of less than 30 indicates severe fatigue. The higher the score, the better the quality of life
Measured: Change from baseline FACIT score at 16 weeks
effects of a 16-week GFD versus placebo diet on depression evaluated by the Hospital anxiety and depression scale (HAD)
The HAD scale is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. cut-off point of 8/21 for anxiety or depression
Measured: Change from baseline HAD score at 16 weeks
Variations in the abundance and type of different bacterial species found in the intestinal microbiota for a subgroup of patients
The microbiota will be analyzed in a subgroup of patients (n = 40) using stool samples collected at J0 and S16
Measured: Change from baseline abundance and types of bacteria at 16 weeks
effects of a 16-week GFD versus placebo diet on functional disability asssessed by Bath Ankylosing Spondylitis Functionnal Index (BASFI) questionnaire
Functional disability index consisting of 10 questions. The final score is calculated on 100 points. The higher the score, the greater the handicap.
Measured: Change from baseline BASFI score at 16 weeks and at 24 weeks
effects of a 16-week GFD versus placebo diet on the persistence of fibromyalgia syndrome
the Fibromyalgia rapid screening tool (FIRST) questionnaire makes it possible to screen for fibromyalgia syndrome quickly and easily. The FIRST questionnaire consists of 6 questions. A score of 5/6 or higher indicates definite fibromyalgia syndrome
Measured: Persistence of fibromyalgia syndrome at week 16 and 24 (if present at inclusion)
Evaluation of compliance with the GFD by an interview with the dietician
The patient's compliance to the GFD will be evaluated by the dietician using an online 3-day alimentary questionnaire. The patient will have to postpone all food consumed and its quantity during the last 3 days before the consultation with the dietician
Measured: at week 16
effects of a 16-week GFD versus placebo diet on body mass index (BMI)
The BMI will be calculated by the formula (height/weight²).
Measured: Change from baseline BMI at week 16 and 24
effects of a 16-week GFD versus placebo diet on Homeostasis Model Assessment of insulin resistance (HOMA-IR)
Insulin resistance will be calculated by the following formula : fasting blood glucose (mmol / l) x fasting insulin (μmol/l) /22.5. A score greater than or equal to 3 indicates insulin resistance
Measured: Change from baseline insulin resistance at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start7 Oct 2021
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- PANZANI, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Responsible party
- Sponsor
- Investigators
- Marion Couderc, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274374
- Sponsor's protocol ID
- PHRC IR 2017 COUDERC
- Other IDs
- 2018-A00309-46
- Acronym
- GlutenSPA
- Status last verified
- Jul 2024
- First submitted
- 11 Feb 2020
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Couderc M, Pereira B, Schaeverbeke T, Thomas T, Chapurlat R, Gaudin P, Morel J, Dougados M, Soubrier M. GlutenSpA trial: protocol for a randomised double-blind placebo-controlled trial of the impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis. BMJ Open. 2020 Nov 20;10(11):e038715. doi: 10.1136/bmjopen-2020-038715.
PubMed 33444189
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis: Study Protocol of a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04274374
- Acronym / sponsor ID
- GlutenSPA / PHRC IR 2017 COUDERC
- Conditions
- Ankylosing Spondyloarthritis
- Keywords
- spondyloarthritis, ankylosing spondylitis, gluten-free diet, gut microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- PANZANI, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 18 Feb 2020 (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.
Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.
Detailed description
The GlutenSpA study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day. The control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day.
At baseline, the dietician will explain to the patients how to properly follow a GFD during a face-to-face interview. The patient's compliance to the GFD will be evaluated by the dietician at S2, S16, an S24 using an online 3-day alimentary questionnaire.
The bread and penne pasta were chosen for their visual resemblance and similar taste to maximize the blindness of the study. In order to reach the daily amount of gluten in a standard diet (estimated in France between 10 and 15 g/d) in the control arm, each day patients will have to ingest six capsules of vital gluten wheat made for the study. Vital gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a base for making products, such as seitan. Capsules will be made using commercially available vital gluten and contain 0.35 g of gluten per capsule. The total amount of gluten in the control arm will be approximately 10.5 g/day.
After the 16-week GFD, patients will be offered to follow or not follow the GFD according to their own decision for an 8-week open-labelled follow-up period. The study duration for each patient is 24 weeks. The patient recruitment is expected to last 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Dietary Supplement: Gluten-Free DietIn the experimental arm will receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day |
| control arm | Active comparator | Dietary Supplement: Gluten Dietthe control arm will received 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of axial SpA defined by ASAS criteria
- Rheumatologist not wish to change the treatment within 4 months of inclusion,
- stable treatment (NSAID and/or DMARD) for at least 3 months but no corticosteroid infiltration in the month prior to inclusion,
- able to follow a GFD and to provide written informed consent and submit to the requirements of the study
Key exclusion criteria (6 listed)
- Any diet at the time of inclusion or within 3 months prior to inclusion;
- have a history of celiac disease;
- received antibiotic treatment within 3 months of inclusion or are taking a probiotic;
- are pregnant, breastfeeding,
- not covered by social security;
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 |
|---|---|---|
| Gluten-Free DietDietary supplement without gluten | Dietary supplement | experimental arm |
| Gluten DietDietary supplement with gluten | Dietary supplement | control arm |
Primary outcome
Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index
Time frame: Change from baseline ASAS HI score at 16 weeks
The self-report questionnaire measures functioning and health across 17 aspects of health and 9 environmental factors (EF) in patients with SpA. The total sum of the ASAS HI ranges from 0-17, with a lower score indicating a better health status.
11 secondary outcomes
effects of a 16-week GFD versus placebo diet on the activity of SpA evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
Time frame: Change from baseline BASDAI score at 16 weeks
effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the erythrocyte sedimentation rate (ESR).
Time frame: Change from baseline ESR at 16 weeks
effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the C-reactive protein (CRP)
Time frame: Change from baseline CRP at 16 weeks
effects of a 16-week GFD versus placebo diet on fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
Time frame: Change from baseline FACIT score at 16 weeks
effects of a 16-week GFD versus placebo diet on depression evaluated by the Hospital anxiety and depression scale (HAD)
Time frame: Change from baseline HAD score at 16 weeks
Variations in the abundance and type of different bacterial species found in the intestinal microbiota for a subgroup of patients
Time frame: Change from baseline abundance and types of bacteria at 16 weeks
effects of a 16-week GFD versus placebo diet on functional disability asssessed by Bath Ankylosing Spondylitis Functionnal Index (BASFI) questionnaire
Time frame: Change from baseline BASFI score at 16 weeks and at 24 weeks
effects of a 16-week GFD versus placebo diet on the persistence of fibromyalgia syndrome
Time frame: Persistence of fibromyalgia syndrome at week 16 and 24 (if present at inclusion)
Evaluation of compliance with the GFD by an interview with the dietician
Time frame: at week 16
effects of a 16-week GFD versus placebo diet on body mass index (BMI)
Time frame: Change from baseline BMI at week 16 and 24
effects of a 16-week GFD versus placebo diet on Homeostasis Model Assessment of insulin resistance (HOMA-IR)
Time frame: Change from baseline insulin resistance at week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 33444189Couderc M, Pereira B, Schaeverbeke T, Thomas T, Chapurlat R, Gaudin P, Morel J, Dougados M, Soubrier M. GlutenSpA trial: protocol for a randomised double-blind placebo-controlled trial of the impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis. BMJ Open. 2020 Nov 20;10(11):e038715. doi: 10.1136/bmjopen-2020-038715.
- 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.
Marion Couderc, MD principal investigator
University Hospital, Clermont-Ferrand
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-Free Diet and Gluten Diet in people with Ankylosing Spondyloarthritis, run by University Hospital, Clermont-Ferrand at 7 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre, Pharm D (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index (time frame: Change from baseline ASAS HI score at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04274374, which also lists 1 linked publication.
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 8 Jul 2024.