Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

NCT ID: NCT04205500

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Specific carbohydrate diet

Intervention Type OTHER

Specific carbohydrate diet (see arm description)

Interventions

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Specific carbohydrate diet

Specific carbohydrate diet (see arm description)

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Swedish University of Agricultural Sciences

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Lillemor Berntson

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lillemor Berntson, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Unit of Pediatric Rheumatology, Akademiska hospital, Uppsala University, Sweden

Locations

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Unit of Pediatric Rheumatology, Akademiska hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lillemor Berntson, Ass Prof

Role: CONTACT

+46703706965

Anders Öman, Md

Role: CONTACT

+4618610000

Facility Contacts

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Lillemor Berntson, Ass Prof

Role: primary

+46703706965

Elin van Ihren, Nurse

Role: backup

+46186110000

References

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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.

Reference Type DERIVED
PMID: 34112181 (View on PubMed)

Other Identifiers

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Dnr 2016/263

Identifier Type: -

Identifier Source: org_study_id

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