Nutritional Therapy Study in Pediatric Crohn's Disease
NCT02610101 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2019-05-24
Summary
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?
Conditions
Interventions
- OTHER
-
Traditional SCD Diet
Traditional SCD includes removal of all processed foods as well as all grains, sweetners except for honey and all diary except for yogurt fermented for over 24hrs and some hard cheeses
- OTHER
-
Modified SCD Diet
Food components of the traditional SCD with the addition of rice and oats.
- OTHER
-
Whole foods diet
A whole foods diet with removal of processed foods. Removal of corn, wheat, sugar and milk are also apart of this dietary regime.
Sponsors & Collaborators
-
Seattle Children's Hospital
lead OTHER
Principal Investigators
-
David L Suskind, MD · Seattle Children's Hospital and The University of Washington
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 12 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- United States
Study Locations
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