Feasibility of a Diet Intervention for Juvenile Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2028-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Juvenile Arthritis, Childhood Juvenile Idiopathic Arthritis

Keywords

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arthritis diet microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Diet (MedDiet)

Group Type EXPERIMENTAL

Diet intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Brian M. Feldman

Division Chief Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian M. Feldman

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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