Juvenile Idiopathic Arthritis Clinical Trial
— JIAOfficial title:
Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Unit of Pediatric Rheumatology, Akademiska hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Karolinska Institutet, Swedish University of Agricultural Sciences |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number of inflamed joints | Physical examination | At baseline compared to four weeks of intervention | |
Primary | Change in CHAQ, child health assessment questionnaire | A questionnaire for assessment of physical function, min-max, 0-3. A higher score means worse physical function | At baseline compared to four weeks of intervention | |
Primary | Change in overall well-being | Global assessment visual analogue scale (VAS), for the patient min-max, 0-10 cm. A higher score means worse overall well-being | At baseline compared to four weeks of intervention | |
Primary | Change in assessment of pain: visual analogue scale | Global assessment visual analogue scale (VAS) for Pain, min-max, 0-10 cm. A higher score means more pain | At baseline compared to four weeks of intervention | |
Primary | Change in assessment of morning stiffness | Number of minutes | At baseline compared to four weeks of intervention | |
Secondary | Change in Microbiota in fecal samples | 16sSrRNA and Metagenomics | At baseline compared to four weeks of intervention | |
Secondary | Change in Short chain fatty acids in fecal samples | Analysed, using a HPLC-machine, Agilent technology 1100-series, presented in mg/gr | At baseline compared to four weeks of intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
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