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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 14
- 主要终点
- Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index
时间窗: 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.
次要结局
- effects of a 16-week GFD versus placebo diet on the activity of SpA evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).(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).(Change from baseline ESR 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.(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)(Change from baseline HAD score at 16 weeks)
- effects of a 16-week GFD versus placebo diet on Homeostasis Model Assessment of insulin resistance (HOMA-IR)(Change from baseline insulin resistance at week 16)
- effects of a 16-week GFD versus placebo diet on the persistence of fibromyalgia syndrome(Persistence of fibromyalgia syndrome at week 16 and 24 (if present at inclusion))
- Variations in the abundance and type of different bacterial species found in the intestinal microbiota for a subgroup of patients(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(Change from baseline BASFI score at 16 weeks and at 24 weeks)
- effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the C-reactive protein (CRP)(Change from baseline CRP at 16 weeks)
- Evaluation of compliance with the GFD by an interview with the dietician(at week 16)
- effects of a 16-week GFD versus placebo diet on body mass index (BMI)(Change from baseline BMI at week 16 and 24)