NCT06474546 Feasibility of a Diet Intervention for Juvenile Arthritis
| NCT ID | NCT06474546 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Arthritis, Juvenile |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2025-04-07 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Brian M. Feldman
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT06474546 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 18 Years, studying Arthritis, Juvenile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06474546 currently recruiting?
Yes, NCT06474546 is actively recruiting participants. Contact the research team at hayyah.clairman@sickkids.ca for enrollment information.
Where is the NCT06474546 trial being conducted?
This trial is being conducted at Winnipeg, Canada, Hamilton, Canada, London, Canada, Ottawa, Canada and 3 additional locations.
Who is sponsoring the NCT06474546 clinical trial?
NCT06474546 is sponsored by The Hospital for Sick Children. The principal investigator is Brian M. Feldman at The Hospital for Sick Children. The trial plans to enroll 54 participants.