The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
McMaster Children's Hospital
NOT_YET_RECRUITING
Hamilton
London Health Sciences Centre
NOT_YET_RECRUITING
London
Centre Hospitalier Universitaire Sainte-Justine
NOT_YET_RECRUITING
Montreal
Children's Hospital of Eastern Ontario (CHEO)
NOT_YET_RECRUITING
Ottawa
Jim Pattison Children's Hospital
NOT_YET_RECRUITING
Saskatoon
The Hospital for Sick Children
RECRUITING
Toronto
University of Manitoba
NOT_YET_RECRUITING
Winnipeg
Contact Information
Primary
Hayyah Clairman
hayyah.clairman@sickkids.ca
416-813-7654
Backup
Kayla Baker
kayla.baker@sickkids.ca
416-813-7654
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2028-10
Participants
Target number of participants: 54
Treatments
Experimental: Intervention
Diet (MedDiet)
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov