Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis

NCT04205500 | Unknown

• 1 other identifier: Dnr 2016/263
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

juvenile; arthritis; diet

Outcome Measures

Primary Outcomes (5)

• Change in number of inflamed joints

  Physical examination

  At baseline compared to four weeks of intervention

• 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

  At baseline compared to four weeks of intervention

• 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

  At baseline compared to four weeks of intervention

• 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

  At baseline compared to four weeks of intervention

• Change in assessment of morning stiffness

  Number of minutes

  At baseline compared to four weeks of intervention

Secondary Outcomes (2)

• Change in Microbiota in fecal samples

  At baseline compared to four weeks of intervention

• Change in Short chain fatty acids in fecal samples

  At baseline compared to four weeks of intervention

Study Arms (1)

Children with juvenile idiopathic arthritis

EXPERIMENTAL

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

Interventions

Specific carbohydrate diet OTHER

Specific carbohydrate diet (see arm description)

Children with juvenile idiopathic arthritis

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants should fulfill criteria for JIA according to the ILAR criteria
• Participants should not be older than 16 years at onset of disease
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Karolinska Institutet: collaborator
• Swedish University of Agricultural Sciences: collaborator

Study Sites (1)

Unit of Pediatric Rheumatology, Akademiska hospital

Uppsala, 75185, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 34112181 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lillemor Berntson, Ass Prof

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lillemor Berntson, Ass Prof

CONTACT

+46703706965; lillemor.berntson@kbh.uu.se

Anders Öman, Md

CONTACT

+4618610000; anders.oman@kbh.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 19, 2019
• Study Start: September 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

SE (1)