Feasibility of a Diet Intervention for Juvenile Arthritis
NCT Number: NCT06474546
Acronym: DIGEST-JA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Arthritis, Juvenile|Arthritis, Childhood|Juvenile Idiopathic Arthritis
Interventions: OTHER: Diet intervention
Sponsor: The Hospital for Sick Children
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: CHILD, ADULT
Enrollment: 54
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2028-10
Locations: University of Manitoba, Winnipeg, Manitoba, R3E 3P4, Canada|McMaster Children's Hospital, Hamilton, Ontario, L8N 3Z5, Canada|London Health Sciences Centre, London, Ontario, N6A 5W9, Canada|Children's Hospital of Eastern Ontario (CHEO), Ottawa, Ontario, K1H 8L1, Canada|The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada|Centre Hospitalier Universitaire Sainte-Justine, Montréal, Quebec, H3T 1C5, Canada|Jim Pattison Children's Hospital, Saskatoon, Saskatchewan, S7N 0W8, Canada

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.

Primary Outcome Measures: (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 Outcome Measures: (Confounder 1) Sleep quality, Measured by FitBit accelerometry, 8-12 weeks|(Confounder 2) Patient-reported Sleep Quality, Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbances questionnaire. The total score ranges from 0-40 with a higher score representing a poor sleep quality., 8-12 weeks|(Confounder 3) Physical activity, Measured by the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GODIN) exercise questionnaire. A total score of 24 or more is active, 14 - 23 is moderately active, and less than 14 units is sedentary., 8-12 weeks|(Confounder 4) Sex, Results will be stratified by sex at birth., 8-12 weeks|(Confounder 5) Gender, Gender will be collected using the Perceived Similarity to Gender Groups Measure for children and youth., 8-12 weeks|(Confounder 6) Medication use, Will be abstracted from the patient chart. Results will be stratified by medication use., 8-12 weeks|(Confounder 7) Age, Stratify data by age group (8 - 12 and 13 - 18), 8-12 weeks