Uppsala university
Uppsala, Uppsala County, 75185, Sweden
NCT Number: NCT04205500
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.
This study is active but is not currently recruiting participants.
Notify MeUp to 16 year
All sexes
Interventional
Not applicable
Uppsala, Uppsala County, 75185, Sweden
Children classified with JIA, in a low-to-medium disease activity and without having changed DMARD or bDMARD in the last 12 weeks are included. Only motivated children and parents can participate. Before inclusion the family are informed orally about the study plan, the diet and practical issues regarding the study and they receive written information including for example a product list and a recipe booklet. A dietician and the principal investigator follows the child and parents during visits, by mail and phone. After the baseline visit, the family has two weeks to get used to the new diet. At baseline, after two, four and twelve weeks on the diet the child is examined, blood exams are performed and blood is stored at -70, fecal samples and urine is also collected. At inclusion and after four weeks saliva sample for bacteria is collected. The child fills in the child health assessment questionnaire, (CHAQ) for a score of the physical ability and DisabKids for an overall assessment of the childs well-being.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific carbohydrate diet (see arm description)
Time frame: At baseline compared to four weeks of intervention
Physical examination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline compared to four weeks of intervention
Number of minutes
Time frame: At baseline compared to four weeks of intervention
16sSrRNA and Metagenomics
Time frame: At baseline compared to four weeks of intervention
Analysed, using a HPLC-machine, Agilent technology 1100-series, presented in mg/gr
Uppsala University
Other
Acronym: JIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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