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Behavioural Intervention

Diet Intervention for Juvenile Arthritis (DIGEST-JA Trial)

N/A
Waitlist Available
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 8-18 years
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8-12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate whether a Mediterranean Diet-based diet can improve arthritis in children by studying its effects on the gut microbiome. Fifty-four participants will change their diet for 8 weeks, with the

Who is the study for?
This trial is for children with juvenile arthritis. Participants will try a Mediterranean-based diet to see if it improves their condition. They must be willing to change their diet, provide stool and blood samples, and complete health questionnaires at specified times during the study.
What is being tested?
The study tests whether a Mediterranean Diet can improve juvenile arthritis by altering the gut microbiome. Fifty-four participants will follow this diet for 8 weeks, with an optional extension of 4 more weeks, while providing samples and information for analysis.
What are the potential side effects?
Since this is a dietary intervention based on the Mediterranean Diet principles, side effects may include changes in bowel habits or food sensitivities but are generally expected to be minimal compared to pharmacological treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 8 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
(Feasibility 1) Participant accrual rate
(Feasibility 2) The proportion of subjects who complete all the various measurement steps
(Feasibility 3) Nutrient intake
+8 more
Secondary study objectives
(Confounder 1) Sleep quality
(Confounder 2) Patient-reported Sleep Quality
(Confounder 3) Physical activity
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Diet (MedDiet)

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
711 Previous Clinical Trials
6,958,226 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,529,391 Total Patients Enrolled
~36 spots leftby Aug 2028
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