Clinical trial NCT06474546: Feasibility of a Diet Intervention for Juvenile Arthritis
Official title: The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis, Juvenile
Arthritis, Childhood
Juvenile Idiopathic Arthritis
Keywords: arthritis
diet
microbiome
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-06-25
Enrollment: 54
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: (Feasibility 1) Participant accrual rate:
timeFrame: 8-12 weeks
measure: (Feasibility 2) The proportion of subjects who complete all the various measurement steps
timeFrame: 8-12 weeks
measure: (Feasibility 3) Nutrient intake
timeFrame: 8-12 weeks
measure: (Feasibility 4) Adherence to the MedDiet
timeFrame: 8-12 weeks
measure: (Feasibility 5) Tolerability of diet intervention
timeFrame: 8-12 weeks
measure: (Mediator 1) Changes in the microbiome
timeFrame: 8-12 weeks
measure: (Mediator 2) Changes in juvenile arthritis disease activity score
timeFrame: 8-12 weeks
measure: (Mediator 3) Changes in functional status
timeFrame: 8-12 weeks
measure: (Mediator 4) Changes in quality of life
timeFrame: 8-12 weeks
measure: (Mediator 5) Changes in gut inflammation
timeFrame: 8-12 weeks
measure: (Mediator 6) Changes in systemic inflammation
timeFrame: 8-12 weeks
Secondary outcomes:
measure: (Confounder 1) Sleep quality
timeFrame: 8-12 weeks
measure: (Confounder 2) Patient-reported Sleep Quality
timeFrame: 8-12 weeks
measure: (Confounder 3) Physical activity
timeFrame: 8-12 weeks
measure: (Confounder 4) Sex
timeFrame: 8-12 weeks
measure: (Confounder 5) Gender
timeFrame: 8-12 weeks
measure: (Confounder 6) Medication use
timeFrame: 8-12 weeks
measure: (Confounder 7) Age
timeFrame: 8-12 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario (CHEO)
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
city: Saskatoon
country: Canada
facility: Jim Pattison Children's Hospital
state: Saskatchewan
Study officials:
affiliation: The Hospital for Sick Children
name: Brian M. Feldman
role: PRINCIPAL_INVESTIGATOR
References: