Feasibility of a Diet Intervention for Juvenile Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet intervention.
- Who it may be relevant to
- Registry conditions: Arthritis, Juvenile, Arthritis, Childhood, Juvenile Idiopathic Arthritis. Basic parameters: 8 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
Overview
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.
Interventions
- Other Diet intervention
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.
Primary outcome measures
- (Feasibility 1) Participant accrual rate: [Time frame: 8-12 weeks]
- (Feasibility 2) The proportion of subjects who complete all the various measurement steps [Time frame: 8-12 weeks]
- (Feasibility 3) Nutrient intake [Time frame: 8-12 weeks]
- (Feasibility 4) Adherence to the MedDiet [Time frame: 8-12 weeks]
- (Feasibility 5) Tolerability of diet intervention [Time frame: 8-12 weeks]
- (Mediator 1) Changes in the microbiome [Time frame: 8-12 weeks]
- (Mediator 2) Changes in juvenile arthritis disease activity score [Time frame: 8-12 weeks]
- (Mediator 3) Changes in functional status [Time frame: 8-12 weeks]
- (Mediator 4) Changes in quality of life [Time frame: 8-12 weeks]
- (Mediator 5) Changes in gut inflammation [Time frame: 8-12 weeks]
Secondary outcome measures (7)
- (Confounder 1) Sleep quality [Time frame: 8-12 weeks]
- (Confounder 2) Patient-reported Sleep Quality [Time frame: 8-12 weeks]
- (Confounder 3) Physical activity [Time frame: 8-12 weeks]
- (Confounder 4) Sex [Time frame: 8-12 weeks]
- (Confounder 5) Gender [Time frame: 8-12 weeks]
- (Confounder 6) Medication use [Time frame: 8-12 weeks]
- (Confounder 7) Age [Time frame: 8-12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 7 centers
- University of Manitoba — Winnipeg
- McMaster Children's Hospital — Hamilton
- London Health Sciences Centre — London
- Children's Hospital of Eastern Ontario (CHEO) — Ottawa
- The Hospital for Sick Children — Toronto
- Centre Hospitalier Universitaire Sainte-Justine — Montreal
- University of Saskatchewan — Saskatoon
Identifiers
NCT: NCT06474546 · 1000080845