NCT04205500

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Sep 2017Dec 2026

Study Start

First participant enrolled

September 1, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

9.3 years

First QC Date

December 12, 2019

Last Update Submit

August 25, 2026

Conditions

Keywords

juvenilearthritisdiet

Outcome Measures

Primary Outcomes (5)

  • Change in number of inflamed joints

    Physical examination

    At baseline compared to four weeks of intervention

  • 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

  • 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

  • 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

  • Change in assessment of morning stiffness

    Number of minutes

    At baseline compared to four weeks of intervention

Secondary Outcomes (2)

  • Change in Microbiota in fecal samples

    At baseline compared to four weeks of intervention

  • Change in Short chain fatty acids in fecal samples

    At baseline compared to four weeks of intervention

Study Arms (1)

Children with juvenile idiopathic arthritis

EXPERIMENTAL

The 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.

Other: Specific carbohydrate diet

Interventions

Specific carbohydrate diet (see arm description)

Children with juvenile idiopathic arthritis

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants should fulfill criteria for JIA according to the ILAR criteria
  • Participants should not be older than 16 years at onset of disease
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala university

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Arthritis, JuvenileArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct professor

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 19, 2019

Study Start

September 1, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations