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Juvenile Idiopathic ArthritisJIANCT04205500

Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

A study testing Specific carbohydrate diet in people with Juvenile Idiopathic Arthritis, run by Uppsala University at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Juvenile Idiopathic Arthritis
What is being tested?
Specific carbohydrate diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSweden
Study dates
1 Sep 2017to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala university

    Uppsala, Uppsala County, 75185

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Specific carbohydrate diet
Keywords
juvenile, arthritis, diet
Medical subject headings
Arthritis, Juvenile, Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specific carbohydrate dietOther

    Specific carbohydrate diet (see arm description)

Study groups in NCT04205500
Study groupRoleWhat they receive
Children with juvenile idiopathic arthritisExperimentalThe specific carbohydrate diet has been shown to have beneficial effects on IBD and has been implemented in Seattle Children's IBD centre, with some patients using SCD either as primary or complementary therapy. The SCD is a nutritionally balanced diet focused on removing many complex carbohydrates such as grains, dairy products except for yoghurt fermented over 24 hours, vegetables rich in starch and sugars except for monosaccharides like in honey. Participants can eat meat but since it has to be unprocessed food the investigator's experience is that the amounts of meat are not very big. Fish, eggs, sea-food is allowed. Bread is baked from nut and almond flour.
Receives: Other: Specific carbohydrate diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in number of inflamed joints

    Physical examination

    Measured: At baseline compared to four weeks of intervention

  2. 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

    Measured: At baseline compared to four weeks of intervention

  3. 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

    Measured: At baseline compared to four weeks of intervention

  4. 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

    Measured: At baseline compared to four weeks of intervention

  5. Change in assessment of morning stiffness

    Number of minutes

    Measured: At baseline compared to four weeks of intervention

Secondary outcomes (2)

  1. Change in Microbiota in fecal samples

    16sSrRNA and Metagenomics

    Measured: At baseline compared to four weeks of intervention

  2. Change in Short chain fatty acids in fecal samples

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

    Measured: At baseline compared to four weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2019
  2. Study start1 Sep 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Except for outcome in clinical variables, JADAS27, CHAQ, Morning stiffness and pain from one month of SCD we are now analyzing possible change in metabolites in plasma samples and possible metagenomic shift in fecal samples.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205500
Sponsor's protocol ID
Dnr 2016/263
Acronym
JIA
Status last verified
Aug 2026
First submitted
12 Dec 2019
Last updated
28 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34112181

  • Berntson L, Oman A, Engstrand L, Dicksved J. A Pilot Study Investigating Faecal Microbiota After Two Dietary Interventions in Children with Juvenile Idiopathic Arthritis. Curr Microbiol. 2022 Jun 7;79(7):215. doi: 10.1007/s00284-022-02899-1.

    PubMed 35672613

  • Hagstrom N, Lovestam E, Koochek A, Berntson L. A qualitative evaluation of the specific carbohydrate diet for juvenile idiopathic arthritis based on children's and parents' experiences. Pediatr Rheumatol Online J. 2023 Oct 19;21(1):127. doi: 10.1186/s12969-023-00914-8.

    PubMed 37858222

  • Hagstrom N, Koochek A, Warensjo Lemming E, Oman A, Arnell H, Berntson L. Exploring nutritional risks of the specific carbohydrate diet: food and nutrient intake in children with juvenile idiopathic arthritis. J Nutr Sci. 2025 Jan 23;14:e9. doi: 10.1017/jns.2024.92. eCollection 2025.

    PubMed 39943929

  • Hagstrom N, Oman A, Koochek A, Arnell H, Berntson L. One-year follow-up of a short specific carbohydrate diet intervention in children with juvenile idiopathic arthritis: A retrospectively controlled study with focus on medical burden. Clin Rheumatol. 2025 May;44(5):2031-2041. doi: 10.1007/s10067-025-07421-z. Epub 2025 Apr 2.

    PubMed 40172812

Questions about this trial

What is this clinical trial studying?

A study testing Specific carbohydrate diet in people with Juvenile Idiopathic Arthritis, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in number of inflamed joints (time frame: At baseline compared to four weeks of intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04205500, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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