Feasibility of a Diet Intervention for Juvenile Arthritis (NCT06474546)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (3 items).
Location: University of Manitoba — Winnipeg, Manitoba
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- University of Manitoba — Winnipeg, Manitoba
- McMaster Children's Hospital — Hamilton, Ontario
- London Health Sciences Centre — London, Ontario
- Children's Hospital of Eastern Ontario (CHEO) — Ottawa, Ontario
- The Hospital for Sick Children — Toronto, Ontario
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec
- University of Saskatchewan — Saskatoon, Saskatchewan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.