- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04205500
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
Conditions
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
- Name: Lillemor Berntson, Ass Prof
- Phone Number: +46703706965
- Email: lillemor.berntson@kbh.uu.se
Study Contact Backup
- Name: Anders Öman, Md
- Phone Number: +4618610000
- Email: anders.oman@kbh.uu.se
Study Locations
-
-
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Uppsala, Sweden, 75185
- Recruiting
- Unit of Pediatric Rheumatology, Akademiska hospital
-
Contact:
- Lillemor Berntson, Ass Prof
- Phone Number: +46703706965
- Email: lillemor.berntson@kbh.uu.se
-
Contact:
- Elin van Ihren, Nurse
- Phone Number: +46186110000
- Email: elin.van.iren@akademiska.se
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-
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID 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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