Feasibility of a Diet Intervention for Juvenile Arthritis

NCT06474546 | Recruiting

• 1 other identifier: 1000080845
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 7

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.

Conditions

Arthritis, Juvenile; Arthritis, Childhood; Juvenile Idiopathic Arthritis

Keywords

arthritis; diet; microbiome

Outcome Measures

Primary Outcomes (11)

• (Feasibility 1) Participant accrual rate:

  The proportion of all subjects who are approached that enroll and the accrual frequency at each site.

  8-12 weeks

• (Feasibility 2) The proportion of subjects who complete all the various measurement steps

  Including return of the fecal samples, gender identification, completion rate of the food diary, etc. The proportion of subjects who continue in the 12-week extension will be recorded.

  8-12 weeks

• (Feasibility 3) Nutrient intake

  Measured by the participants completing an ecologic momentary assessment (EMA) food diary and the corresponding Prospective Urban Rural Epidemiology (PURE) scores. The PURE score is calculated based on what the subjects entered in their EMA food diary. The score is from 0-6, with a higher score representing a healthier diet.

  8-12 weeks

• (Feasibility 4) Adherence to the MedDiet

  Measured by Mediterranean Diet Quality Index in children and adolescents (KIDMED) a questionnaire that measures adherence to the MedDiet scores. The index ranges from 0-12. The values are classified into three levels: \> 8 is optimal MedDiet, 4-7 means improvement needed to adjust intake to MedDiet patterns, and ≤ 3 is low diet quality.

  8-12 weeks

• (Feasibility 5) Tolerability of diet intervention

  Tolerability will be measured by the Gastrointestinal Symptom Scale for Kids (GISSK), a well-validated and simple questionnaire, designed for use in juvenile idiopathic arthritis (JIA). There are 2 parts to the scale. A visual analog scale (VAS) from 0-100 where the higher score represents the higher severity of gastrointestinal symptoms. And a 8-part questionnaire that ranges from 0-8 where 0 represents no gastrointestinal symptoms.

  8-12 weeks

• (Mediator 1) Changes in the microbiome

  Measured by intestinal microbial ⍺-diversity (a measure representing the number of microbial groups and how evenly balanced they are within the gut), the individual species and functions of gut organisms (through shotgun metagenomics), and short chain fatty acids (SCFAs).

  8-12 weeks

• (Mediator 2) Changes in juvenile arthritis disease activity score

  Measured by the Juvenile Arthritis Disease Activity Scale (cJADAS10). This includes the 1) physician's global assessment of disease activity measured on a 10cm visual analog scale (VAS), (2) parent/patient's global assessment of well-being measured on a 10cm VAS, (3) count of joints with active disease up to 10 active joints. The total score ranges from 0-30 with higher number representing a higher juvenile arthritis disease activity score.

  8-12 weeks

• (Mediator 3) Changes in functional status

  Measured by the Childhood Health Assessment Questionnaire (CHAQ) (self/parent report scale that is widely used to measure functional status in children with arthritis). The score ranges from 0-3, with a 0 representing no functional disability and 3 representing severe disability.

  8-12 weeks

• (Mediator 4) Changes in quality of life

  Measured by the Quality of My Life (QoML) questionnaire (a validated questionnaire to measure well-being). QoML consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.

  8-12 weeks

• (Mediator 5) Changes in gut inflammation

  Measured by fecal calprotectin.

  8-12 weeks

• (Mediator 6) Changes in systemic inflammation

  Measured by a blood biomarker panel, a composite measure of immune activation comprising 49 analytes: (sCD40L, EGF, Eotaxin, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GROα, IFNα2, IFNγ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IL-17E/IL-25, IL-17F, IL-18, IL-22, IL-27, IP-10, MCP-1, MCP-3, M-CSF, MDC (CCL22), MIG, MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGFα, TNFα, TNFβ, VEGF-A, YKL40)

  8-12 weeks

Secondary Outcomes (7)

• (Confounder 1) Sleep quality

  8-12 weeks

• (Confounder 2) Patient-reported Sleep Quality

  8-12 weeks

• (Confounder 3) Physical activity

  8-12 weeks

• (Confounder 4) Sex

  8-12 weeks

• (Confounder 5) Gender

  8-12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Diet (MedDiet)

Other: Diet intervention

Interventions

Diet intervention OTHER

A diet based on the principles of the Mediterranean Diet (MedDiet): consists of an abundance of plant foods - unrefined cereals, fruit, vegetables, and extra-virgin olive oil - a moderate consumption of poultry, dairy products, eggs, and low consumption of sweets and red meats. All subjects will be instructed to follow the MedDiet for 8 weeks by the study team. Families will be given the option to continue for 12 weeks if they wish to do so.

Intervention

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (7)

University of Manitoba

Winnipeg, Manitoba, R3E 3P4, Canada

NOT YET RECRUITING

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Children's Hospital of Eastern Ontario (CHEO)

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

NOT YET RECRUITING

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brian M. Feldman

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayyah Clairman

CONTACT

416-813-7979; hayyah.clairman@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief Rheumatology

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 25, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CA (7)