Mediterranean-style diet for children with juvenile arthritis
The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
This study will try a Mediterranean-style diet in children aged 8–18 with juvenile idiopathic arthritis to see if it improves arthritis symptoms and changes the gut microbiome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 8 Years to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 7 sites (Winnipeg, Manitoba and 6 other locations) |
| Trial ID | NCT06474546 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 8–18 with juvenile idiopathic arthritis (excluding systemic JIA, enthesitis-related arthritis, and RF-positive polyarthritis) who are on stable medications, fluent in English or French, and willing to provide stool samples and follow diet instructions.
Not a fit: Children with excluded JIA subtypes, documented food allergies or celiac disease, or major comorbidities that affect diet (such as type 1 diabetes) are unlikely to be eligible and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, the diet could reduce arthritis symptoms and improve gut health, offering a low-risk, non-drug option to complement current treatments.
How similar studies have performed: Prior research in adults and some pediatric work has shown Mediterranean-style diets can reduce inflammation and alter the gut microbiome, but randomized data specifically in juvenile idiopathic arthritis are limited, so this approach is promising but not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Winnipeg, Manitoba and 6 other locations
- University of Manitoba — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
- McMaster Children's Hospital — Hamilton, Ontario, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Children's Hospital of Eastern Ontario (CHEO) — Ottawa, Ontario, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Ontario, Canada (Active_not_recruiting)
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada (Not_yet_recruiting)
- Jim Pattison Children's Hospital — Saskatoon, Saskatchewan, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.