The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 17
- 主要终点
- (Feasibility 1) Participant accrual rate:
研究概览
简要总结
Families of children with arthritis are highly interested in the benefits of diet to improve their child's disease and future health outcomes. Previous research shows that the germs - bacteria and other organisms - that live in the intestines (gut microbiome) are important to how well immune systems work, and that what people eat changes their gut microbiome. The investigators want to study whether a certain diet - based on the principles of the Mediterranean Diet - will improve arthritis for children and whether it was changes in the microbiome that led to improvement.
Fifty-four participants in this study will change their diet for an 8-week period, and will have the option of remaining on the diet for an additional 4 weeks. At three time points during the study (beginning, 8 weeks, and 12 weeks), participants will provide stool and blood samples, will complete questionnaires about diet and other aspects of lifestyle and health, and will complete a disease assessment by a clinician. From collecting all these samples and information, the investigators will be able to determine if the diet was successful in improving disease activity in children with arthritis and if the gut microbiome was changed as well.
This study will help the investigators figure out if a larger, and more definitive, study like this is possible to do in children with arthritis and will help the investigators design a bigger multinational study to confirm how diet affects disease outcomes and the microbiome in children with arthritis. If successful, this research will provide scientific knowledge to help families make their way through this difficult to- navigate topic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 8-18 years
- •Diagnosis of JIA (excluding systemic JIA, enthesitis-related arthritis, and rheumatoid factor (RF) positive polyarthritis) as per International League of Associations for Rheumatology (ILAR) criteria. (For this feasibility study, there will be no requirement for any particular level of disease activity.)
- •Subjects on stable treatment - i.e., any medical treatment with disease-modifying antirheumatic drugs (DMARDs) and/or systemic or intraarticular corticosteroids, has been unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by the treating physician.
- •Willingness to provide stool samples.
- •English or French fluency adequate to answer the study questionnaires, and participate in diet instruction, as judged by the enrolling physician.
排除标准
- •Documented specific food allergies, celiac disease.
- •Co-morbidities that might impact the tolerability of the study diet, e.g., type I diabetes, peptic ulcer disease, etc.
研究组 & 干预措施
Intervention
Diet (MedDiet)
干预措施: Diet intervention (Other)
结局指标
主要结局
(Feasibility 1) Participant accrual rate:
时间窗: 8-12 weeks
The proportion of all subjects who are approached that enroll and the accrual frequency at each site.
(Feasibility 5) Tolerability of diet intervention
时间窗: 8-12 weeks
Tolerability will be measured by the Gastrointestinal Symptom Scale for Kids (GISSK), a well-validated and simple questionnaire, designed for use in juvenile idiopathic arthritis (JIA). There are 2 parts to the scale. A visual analog scale (VAS) from 0-100 where the higher score represents the higher severity of gastrointestinal symptoms. And a 8-part questionnaire that ranges from 0-8 where 0 represents no gastrointestinal symptoms.
(Feasibility 2) The proportion of subjects who complete all the various measurement steps
时间窗: 8-12 weeks
Including return of the fecal samples, gender identification, completion rate of the food diary, etc. The proportion of subjects who continue in the 12-week extension will be recorded.
(Feasibility 4) Adherence to the MedDiet
时间窗: 8-12 weeks
Measured by Mediterranean Diet Quality Index in children and adolescents (KIDMED) a questionnaire that measures adherence to the MedDiet scores. The index ranges from 0-12. The values are classified into three levels: \> 8 is optimal MedDiet, 4-7 means improvement needed to adjust intake to MedDiet patterns, and ≤ 3 is low diet quality.
(Mediator 1) Changes in the microbiome
时间窗: 8-12 weeks
Measured by intestinal microbial ⍺-diversity (a measure representing the number of microbial groups and how evenly balanced they are within the gut), the individual species and functions of gut organisms (through shotgun metagenomics), and short chain fatty acids (SCFAs).
(Mediator 3) Changes in functional status
时间窗: 8-12 weeks
Measured by the Childhood Health Assessment Questionnaire (CHAQ) (self/parent report scale that is widely used to measure functional status in children with arthritis). The score ranges from 0-3, with a 0 representing no functional disability and 3 representing severe disability.
(Mediator 4) Changes in quality of life
时间窗: 8-12 weeks
Measured by the Quality of My Life (QoML) questionnaire (a validated questionnaire to measure well-being). QoML consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.
(Feasibility 3) Nutrient intake
时间窗: 8-12 weeks
Measured by the participants completing an ecologic momentary assessment (EMA) food diary and the corresponding Prospective Urban Rural Epidemiology (PURE) scores. The PURE score is calculated based on what the subjects entered in their EMA food diary. The score is from 0-6, with a higher score representing a healthier diet.
(Mediator 2) Changes in juvenile arthritis disease activity score
时间窗: 8-12 weeks
Measured by the Juvenile Arthritis Disease Activity Scale (cJADAS10). This includes the 1) physician's global assessment of disease activity measured on a 10cm visual analog scale (VAS), (2) parent/patient's global assessment of well-being measured on a 10cm VAS, (3) count of joints with active disease up to 10 active joints. The total score ranges from 0-30 with higher number representing a higher juvenile arthritis disease activity score.
(Mediator 5) Changes in gut inflammation
时间窗: 8-12 weeks
Measured by fecal calprotectin.
(Mediator 6) Changes in systemic inflammation
时间窗: 8-12 weeks
Measured by a blood biomarker panel, a composite measure of immune activation comprising 49 analytes: (sCD40L, EGF, Eotaxin, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GROα, IFNα2, IFNγ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IL-17E/IL-25, IL-17F, IL-18, IL-22, IL-27, IP-10, MCP-1, MCP-3, M-CSF, MDC (CCL22), MIG, MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGFα, TNFα, TNFβ, VEGF-A, YKL40)
次要结局
- (Confounder 6) Medication use(8-12 weeks)
- (Confounder 1) Sleep quality(8-12 weeks)
- (Confounder 2) Patient-reported Sleep Quality(8-12 weeks)
- (Confounder 3) Physical activity(8-12 weeks)
- (Confounder 7) Age(8-12 weeks)
- (Confounder 4) Sex(8-12 weeks)
- (Confounder 5) Gender(8-12 weeks)
研究者
Brian M. Feldman
Division Chief Rheumatology
The Hospital for Sick Children