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Search / Trial NCT06474546

Feasibility of a Diet Intervention for Juvenile Arthritis

Launched by THE HOSPITAL FOR SICK CHILDREN · Jun 19, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Arthritis Diet Microbiome

ClinConnect Summary

This clinical trial is exploring whether a diet similar to the Mediterranean Diet can help improve arthritis symptoms in children and teenagers aged 8 to 18 who have a specific type of juvenile arthritis. Researchers believe that the bacteria in our intestines, known as the gut microbiome, play a role in how our immune system works, and that changing what we eat can affect this microbiome. In this study, 54 young participants will follow the new diet for 8 weeks, with an option to continue for an additional 4 weeks. Throughout the study, they will provide stool and blood samples, answer questions about their diet and health, and have their arthritis assessed by a doctor.

To be eligible for this study, children must be between 8 and 18 years old and have a diagnosis of juvenile idiopathic arthritis (excluding certain types). They should also be on stable medication that hasn’t changed for at least 8 weeks. The trial does not require any specific level of disease activity, but it’s important for participants to be willing to provide stool samples and be able to understand instructions in English or French. This research aims to determine if a larger study is possible in the future and how diet may influence health outcomes and the gut microbiome in young people with arthritis. If successful, it could offer valuable insights for families navigating dietary choices in managing this condition.

Gender

ALL

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.

About The Hospital For Sick Children

The Hospital for Sick Children (SickKids) is a leading pediatric health care and research institution located in Toronto, Canada. With a commitment to advancing child health through innovative research, education, and clinical care, SickKids is recognized globally for its expertise in pediatric medicine. The hospital actively sponsors clinical trials aimed at improving treatment outcomes and enhancing the quality of life for children with various health conditions. By fostering collaboration among multidisciplinary teams and leveraging state-of-the-art facilities, SickKids strives to translate research findings into tangible advancements in pediatric care, ensuring that children receive the best possible treatments based on the latest scientific evidence.

Locations

Winnipeg, Manitoba, Canada

London, Ontario, Canada

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Montréal, Quebec, Canada

Ottawa, Ontario, Canada

Saskatoon, Saskatchewan, Canada

Toronto, Ontario (On), Canada

Patients applied

0 patients applied

Trial Officials

Brian M. Feldman

Principal Investigator

The Hospital for Sick Children

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported