Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

Not Applicable

• Conditions: Juvenile Idiopathic Arthritis

• Registration Number: NCT04205500
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-26
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in number of inflamed joints	At baseline compared to four weeks of intervention	Physical examination
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 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 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 assessment of morning stiffness	At baseline compared to four weeks of intervention	Number of minutes

Secondary Outcome Measures

Name	Time	Method
Change in Microbiota in fecal samples	At baseline compared to four weeks of intervention	16sSrRNA and Metagenomics
Change in Short chain fatty acids in fecal samples	At baseline compared to four weeks of intervention	Analysed, using a HPLC-machine, Agilent technology 1100-series, presented in mg/gr

Trial Locations

Locations (1)

Unit of Pediatric Rheumatology, Akademiska hospital; 🇸🇪 Uppsala, Sweden