Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis

Completed · Not applicable

Conditions studied: Crohn's Disease, Ulcerative Colitis

In brief

The aim of this study is to determine the tolerability and potential efficacy of dietary therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to determine tolerability, preliminary safety and potential efficacy in pediatric patients with CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of 10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the study for approximately 12 weeks.

Key facts

Study ID

NCT02213835

Run by

David Suskind

People needed

9

Starts

2014-06-01

Expected to finish

2017-09-01

Last updated by the study team

2019-05-24

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents eight to twenty one years old
• Diagnosis of Ulcerative colitis or 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) or PUCAI score (10-60)
• 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 or PUCAI >60
• Active or history of intraabdominal abscess, intraabdominal 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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