Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis (JIA)

August 25, 2026 updated by: Lillemor Berntson, Uppsala University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 75185
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Children with juvenile idiopathic arthritis
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
Specific carbohydrate diet (see arm description)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in number of inflamed joints
Time Frame: At baseline compared to four weeks of intervention
Physical examination
At baseline compared to four weeks of intervention
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
At baseline compared to four weeks of intervention
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
At baseline compared to four weeks of intervention
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
At baseline compared to four weeks of intervention
Change in assessment of morning stiffness
Time Frame: At baseline compared to four weeks of intervention
Number of minutes
At baseline compared to four weeks of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Microbiota in fecal samples
Time Frame: At baseline compared to four weeks of intervention
16sSrRNA and Metagenomics
At baseline compared to four weeks of intervention
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
At baseline compared to four weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chalmers University of Technology
The Swedish Rheumatism Ass
Swedish University of Agricultural Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lillemor Berntson, Ass Prof, Unit of Pediatric Rheumatology, Akademiska hospital, Uppsala University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2016/263

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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