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

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Specific carbohydrate diet
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring juvenile, arthritis, diet

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Unit of Pediatric Rheumatology, Akademiska hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children with juvenile idiopathic arthritis

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in number of inflamed joints
Physical examination
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
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
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
Change in assessment of morning stiffness
Number of minutes

Secondary Outcome Measures

Change in Microbiota in fecal samples
16sSrRNA and Metagenomics
Change in Short chain fatty acids in fecal samples
Analysed, using a HPLC-machine, Agilent technology 1100-series, presented in mg/gr

Full Information

First Posted
December 12, 2019
Last Updated
March 24, 2021
Sponsor
Uppsala University
Collaborators
Karolinska Institutet, Swedish University of Agricultural Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04205500
Brief Title
Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis
Acronym
JIA
Official Title
Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Karolinska Institutet, Swedish University of Agricultural Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
juvenile, arthritis, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with juvenile idiopathic arthritis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Specific carbohydrate diet
Intervention Description
Specific carbohydrate diet (see arm description)
Primary Outcome Measure Information:
Title
Change in number of inflamed joints
Description
Physical examination
Time Frame
At baseline compared to four weeks of intervention
Title
Change in CHAQ, child health assessment questionnaire
Description
A questionnaire for assessment of physical function, min-max, 0-3. A higher score means worse physical function
Time Frame
At baseline compared to four weeks of intervention
Title
Change in overall well-being
Description
Global assessment visual analogue scale (VAS), for the patient min-max, 0-10 cm. A higher score means worse overall well-being
Time Frame
At baseline compared to four weeks of intervention
Title
Change in assessment of pain: visual analogue scale
Description
Global assessment visual analogue scale (VAS) for Pain, min-max, 0-10 cm. A higher score means more pain
Time Frame
At baseline compared to four weeks of intervention
Title
Change in assessment of morning stiffness
Description
Number of minutes
Time Frame
At baseline compared to four weeks of intervention
Secondary Outcome Measure Information:
Title
Change in Microbiota in fecal samples
Description
16sSrRNA and Metagenomics
Time Frame
At baseline compared to four weeks of intervention
Title
Change in Short chain fatty acids in fecal samples
Description
Analysed, using a HPLC-machine, Agilent technology 1100-series, presented in mg/gr
Time Frame
At baseline compared to four weeks of intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lillemor Berntson, Ass Prof
Phone
+46703706965
Email
lillemor.berntson@kbh.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Öman, Md
Phone
+4618610000
Email
anders.oman@kbh.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lillemor Berntson, Ass Prof
Organizational Affiliation
Unit of Pediatric Rheumatology, Akademiska hospital, Uppsala University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Pediatric Rheumatology, Akademiska hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lillemor Berntson, Ass Prof
Phone
+46703706965
Email
lillemor.berntson@kbh.uu.se
First Name & Middle Initial & Last Name & Degree
Elin van Ihren, Nurse
Phone
+46186110000
Email
elin.van.iren@akademiska.se

12. IPD Sharing Statement

Citations:
PubMed Identifier
34112181
Citation
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.
Results Reference
derived

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Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

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