Nutritional Therapy Study in Pediatric Crohn's Disease

Completed · Not applicable

Conditions studied: Crohn's Disease

In brief

The investigators are doing this research study to answer questions about a nutritional therapy called the Specific Carbohydrate Diet (SCD) for children with active Crohn's Disease (CD). The SCDiet is a diet where all grains such as wheat, barley, corn, rice are restricted. Most dairy products (except certain yogurt) are also restricted. The diet mainly consists of meat, fruits, vegetables, nuts, oils and honey, and is offered to individuals with active Crohn's disease as part of standard of care at Seattle Children's. For this study, the investigators will have three different dietary groups: 1. Traditional SCD diet group 2. Modified SCD to include oatmeal and rice 3. SCD with whole foods without added sugar Specifically, the investigators want to know: * Is the SCD well tolerated? * Is SCD effective for the treatment for active Crohn's Disease? * Will the results from the varied three dietary groups have the same results for each patient?

Key facts

Study ID

NCT02610101

Run by

Seattle Children's Hospital

People needed

18

Starts

2015-11-01

Expected to finish

2018-12-01

Last updated by the study team

2019-05-24

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents 8 to 21 years old
• Diagnosis of Crohn's Disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology
• Mild or moderate disease activity based upon PCDAI score (10-45)
• Parent/guardian and child must be able to comprehend the consent and assent
• Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12.
• Patient must not have medication changes for his/her inflammatory bowel disease medications for at least 1 months, unless medically necessary.

You may not qualify if…

• Severe disease with PCDAI >45
• Active or history of intra abdominal abscess, intra abdominal fistula, stricturing Crohn's disease
• Other serious medical conditions such as neurological, liver, kidney, autoimmune or systemic disease.
• Has begun TNF inhibitors within two months prior to study
• Has had change of maintenance medication within the last month
• Tobacco, alcohol or illicit drug abuse
• Pregnant subject recipients will be excluded

Where it is running

• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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