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

March 24, 2021 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

Recruiting

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • 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 Backup

Study Locations

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

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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.
Specific carbohydrate diet (see arm description)

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • 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.

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)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

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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