Clinical Trials in Sweden / NCT04205500
Active, not recruiting
Not applicable
Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis
NCT04205500 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Juvenile Idiopathic Arthritis
Investigational drug(s) / intervention(s)
Specific carbohydrate diet
Specific carbohydrate diet: Specific carbohydrate diet (see arm description)
Study summary
The aim of this study is to explore if an already established diet with anti-inflammatory effect in paediatric inflammatory bowel disease would have an anti-inflammatory effect in children with JIA. The diet is called specific carbohydrate diet.
Eligibility
Inclusion Criteria:
* Participants should fulfill criteria for JIA according to the ILAR criteria
* Participants should not be older than 16 years at onset of disease
* Participants should have a low-medium disease activity with an E-SR of 30 at the most and/or no more than two active joints at inclusion.
* DMARD and bDMARD should not have been changed within the last 12 weeks before inclusion.
* Any gastro- intestinal complaints should be investigated before inclusion.
* Fecal calprotectin should be normal.
* The child as well as the parents need to be motivated for the child to try a dietary intervention for at least four weeks, preferably longer.
Exclusion criteria:
* Children with the systemic category of JIA.
* Children with an unstable inflammatory situation with \> 2 inflamed joints and/or an E-SR of more than 30.
Primary outcome measure(s)
- Change in number of inflamed joints — At baseline compared to four weeks of intervention
Physical examination - Change in CHAQ, child health assessment questionnaire — At baseline compared to four weeks of intervention
A questionnaire for assessment of physical function, min-max, 0-3. A higher score means worse physical function - Change in overall well-being — At baseline compared to four weeks of intervention
Global assessment visual analogue scale (VAS), for the patient min-max, 0-10 cm. A higher score means worse overall well-being - Change in assessment of pain: visual analogue scale — At baseline compared to four weeks of intervention
Global assessment visual analogue scale (VAS) for Pain, min-max, 0-10 cm. A higher score means more pain - Change in assessment of morning stiffness — At baseline compared to four weeks of intervention
Number of minutes
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Uppsala university | Uppsala | Uppsala County |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04205500 on ClinicalTrials.gov ↗ ← All trials in Sweden