Clinical trial NCT04205500: Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis
Official title: Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: juvenile
arthritis
diet
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Swedish University of Agricultural Sciences
First posted: 2019-12-19
Enrollment: 30
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Change in number of inflamed joints
timeFrame: At baseline compared to four weeks of intervention
measure: Change in CHAQ, child health assessment questionnaire
timeFrame: At baseline compared to four weeks of intervention
measure: Change in overall well-being
timeFrame: At baseline compared to four weeks of intervention
measure: Change in assessment of pain: visual analogue scale
timeFrame: At baseline compared to four weeks of intervention
measure: Change in assessment of morning stiffness
timeFrame: At baseline compared to four weeks of intervention
Secondary outcomes:
measure: Change in Microbiota in fecal samples
timeFrame: At baseline compared to four weeks of intervention
measure: Change in Short chain fatty acids in fecal samples
timeFrame: At baseline compared to four weeks of intervention
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Unit of Pediatric Rheumatology, Akademiska hospital
Study officials:
affiliation: Unit of Pediatric Rheumatology, Akademiska hospital, Uppsala University, Sweden
name: Lillemor Berntson, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berntson L. A pilot study of possible anti-inflammatory effects of the specific carbohydrate diet in children with juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2021 Jun 10;19(1):88. doi: 10.1186/s12969-021-00577-3.