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OpenTrials
Active, not recruiting

NCT Number: NCT04205500

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala university

Uppsala, Uppsala County, 75185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specific carbohydrate diet

Other

Specific carbohydrate diet (see arm description)

Primary outcomes

  1. Change in number of inflamed joints

    Time frame: At baseline compared to four weeks of intervention

    Physical examination

  2. Change in CHAQ, child health assessment questionnaire

    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

  3. Change in overall well-being

    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

  4. Change in assessment of pain: visual analogue scale

    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

  5. Change in assessment of morning stiffness

    Time frame: At baseline compared to four weeks of intervention

    Number of minutes

Secondary outcomes

  1. Change in Microbiota in fecal samples

    Time frame: At baseline compared to four weeks of intervention

    16sSrRNA and Metagenomics

  2. Change in Short chain fatty acids in fecal samples

    Time frame: At baseline compared to four weeks of intervention

    Analysed, using a HPLC-machine, Agilent technology 1100-series, presented in mg/gr

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Chalmers University of Technology
  • Swedish University of Agricultural Sciences
  • The Swedish Rheumatism Ass

Registry information

Acronym: JIA

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2019
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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