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Feasibility of a Diet Intervention for Juvenile Arthritis

RecruitingNAAges 8 Years - 18 YearsAllThe Hospital for Sick Children
NCT06474546 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 di

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Diet intervention
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Where

7 sites
University of Manitoba
Winnipeg, Canada
McMaster Children's Hospital
Hamilton, Canada
London Health Sciences Centre
London, Canada
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Canada
The Hospital for Sick Children
Toronto, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Canada
University of Saskatchewan
Saskatoon, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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