Status:
COMPLETED
Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis
Lead Sponsor:
David Suskind
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
All Genders
8-21 years
Phase:
NA
Brief Summary
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 C...
Detailed Description
Ten patients with CD or UC with mild or moderate disease activity as defined by Pediatric Crohn's disease activity index (PCDAI score of 10-29 or PUCAI of 10 - 60) aged 8 -21 years will enroll into th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02213835
Start Date
June 1 2014
End Date
September 1 2017
Last Update
May 24 2019
Active Locations (1)
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1
Seattle Children's Hospital
Seattle, Washington, United States, 98105