Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— JIA  

Official title:

Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04205500
• Other study ID #: Dnr 2016/263
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2021
• Source: Uppsala University
• Contact: Lillemor Berntson, Ass Prof
• Phone: +46703706965
• Email: lillemor.berntson[@]kbh.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Other:
• Specific carbohydrate diet
Specific carbohydrate diet (see arm description)

Locations

Country	Name	City	State
Sweden	Unit of Pediatric Rheumatology, Akademiska hospital	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet, Swedish University of Agricultural Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

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