Feasibility of a Diet Intervention for Juvenile Arthritis

Last updated: June 5, 2025
Sponsor: The Hospital for Sick Children
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Diet intervention

Clinical Study ID

NCT06474546
1000080845
  • Ages 8-18
  • All Genders

Study 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

Inclusion Criteria:

  • Ages 8-18 years

  • Diagnosis of JIA (excluding systemic JIA, enthesitis-related arthritis, andrheumatoid factor (RF) positive polyarthritis) as per International League ofAssociations for Rheumatology (ILAR) criteria. (For this feasibility study, therewill be no requirement for any particular level of disease activity.)

  • Subjects on stable treatment - i.e., any medical treatment with disease-modifyingantirheumatic drugs (DMARDs) and/or systemic or intraarticular corticosteroids, hasbeen unchanged for 8 weeks, and is unlikely to change for 12 weeks as judged by thetreating physician.

  • Willingness to provide stool samples.

  • English or French fluency adequate to answer the study questionnaires, andparticipate in diet instruction, as judged by the enrolling physician.

Exclusion

Exclusion Criteria:

  • Documented specific food allergies, celiac disease.

  • Co-morbidities that might impact the tolerability of the study diet, e.g., type Idiabetes, peptic ulcer disease, etc.

Study Design

Total Participants: 54
Treatment Group(s): 1
Primary Treatment: Diet intervention
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • University of Manitoba

    Winnipeg, Manitoba R3E 3P4
    Canada

    Site Not Available

  • McMaster Children's Hospital

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario (CHEO)

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montréal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Jim Pattison Children's Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

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