NCT Number: NCT06474546
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.
Interested in participating?
Request Info8 year–18 year
All sexes
Interventional
Not applicable
University of Manitoba, Winnipeg, Manitoba, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8-12 weeks
The proportion of all subjects who are approached that enroll and the accrual frequency at each site.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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).
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
Measured by fecal calprotectin.
Time frame: 8-12 weeks
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)
Time frame: 8-12 weeks
Measured by FitBit accelerometry
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
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.
Time frame: 8-12 weeks
Results will be stratified by sex at birth.
Time frame: 8-12 weeks
Gender will be collected using the Perceived Similarity to Gender Groups Measure for children and youth.
Time frame: 8-12 weeks
Will be abstracted from the patient chart. Results will be stratified by medication use.
Time frame: 8-12 weeks
Stratify data by age group (8 - 12 and 13 - 18)
Contact information is provided by the study sponsor or research team.
The Hospital for Sick Children
Other
The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
Acronym: DIGEST-JA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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