Mediterranean-style diet for children with juvenile arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Fifty-four children with juvenile idiopathic arthritis will follow a Mediterranean-style diet for an 8-week period with an optional additional 4-week extension. Stool and blood samples, diet and lifestyle questionnaires, and clinician disease assessments will be collected at baseline, 8 weeks, and 12 weeks. The study will compare clinical disease measures and microbiome composition over time to see whether diet-related microbiome changes accompany any symptom improvements. Eligible participants must be 8–18 years old, fluent in English or French, on stable treatment, and without specific food allergies, celiac disease, or major comorbidities that would affect diet tolerance.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Manitoba
  Winnipeg, Manitoba, Canada Recruiting
• McMaster Children's Hospital
  Hamilton, Ontario, Canada Recruiting
• London Health Sciences Centre
  London, Ontario, Canada Recruiting
• Centre Hospitalier Universitaire Sainte-Justine
  Montreal, Quebec, Canada Recruiting
• Children's Hospital of Eastern Ontario (CHEO)
  Ottawa, Ontario, Canada Active not recruiting
• The Hospital for Sick Children
  Toronto, Ontario, Canada Active not recruiting

Study contacts

• Principal investigator: Brian M. Feldman — The Hospital for Sick Children
• Study coordinator: Hayyah Clairman
• Email: hayyah.clairman@sickkids.ca
• Phone: 416-813-7979

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.