Feasibility of a Diet Intervention for Juvenile Arthritis

Официальное название

The Role of Diet, as Mediated by the Gut Microbiome, on Childhood Arthritis Disease Activity: a Feasibility Intervention Study

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• (Feasibility 1) Participant accrual rate: [Срок оценки: 8-12 weeks]
• (Feasibility 2) The proportion of subjects who complete all the various measurement steps [Срок оценки: 8-12 weeks]
• (Feasibility 3) Nutrient intake [Срок оценки: 8-12 weeks]
• (Feasibility 4) Adherence to the MedDiet [Срок оценки: 8-12 weeks]
• (Feasibility 5) Tolerability of diet intervention [Срок оценки: 8-12 weeks]
• (Mediator 1) Changes in the microbiome [Срок оценки: 8-12 weeks]
• (Mediator 2) Changes in juvenile arthritis disease activity score [Срок оценки: 8-12 weeks]
• (Mediator 3) Changes in functional status [Срок оценки: 8-12 weeks]
• (Mediator 4) Changes in quality of life [Срок оценки: 8-12 weeks]
• (Mediator 5) Changes in gut inflammation [Срок оценки: 8-12 weeks]

Вторичные конечные точки (7)

• (Confounder 1) Sleep quality [Срок оценки: 8-12 weeks]
• (Confounder 2) Patient-reported Sleep Quality [Срок оценки: 8-12 weeks]
• (Confounder 3) Physical activity [Срок оценки: 8-12 weeks]
• (Confounder 4) Sex [Срок оценки: 8-12 weeks]
• (Confounder 5) Gender [Срок оценки: 8-12 weeks]
• (Confounder 6) Medication use [Срок оценки: 8-12 weeks]
• (Confounder 7) Age [Срок оценки: 8-12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 7 центров

• 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

Идентификаторы

NCT: NCT06474546 · 1000080845

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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