Nutritional Therapy Study in Pediatric Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

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?
    

Detailed description: 
      21 patients with CD , mild or moderate disease activity as defined by Pediatric Crohn's
      disease activity index (PCDAI score of 10-45 ) aged 8 -21 years will enroll into this
      study.Patient's will be randomized to treatment groups. The treatments for this study will be
      the:(1) Standard SCD as defined by Elaine Gottschall's Breaking the vicious cycle (2)
      Modified SCD with added oats and rice (3) Whole foods diet without added sugars. Each patient
      will receive an initial evaluation including a physical exam, medication review, nutritional
      guidance and post treatment evaluations.

      Initial evaluation: Study subject recipient will have the following lab tests including CBC
      with differential & platelets, a c-reactive protein, sedimentation rate, an albumin, vitamin
      D level,Cholesterol, Vitamin A, Vitamin E, Zinc, Folate, a stool study for c. difficile, for
      bacterial culture and ova and parasite, stool calprotectin and microbiome. Additionally, the
      investigators will complete a physical exam and document their current medications. The study
      nutritionist will complete a thorough diet history.

      Treatment: Patient's will be randomized to treatment groups. The treatments for this study
      will be the:(1) Standard SCD as defined by Elaine Gottschall's Breaking the vicious cycle (2)
      Modified SCD with added oats and rice (3) Whole foods diet without added sugars Families will
      be given a list of "safe foods" that the patient can eat no matter which group the patient is
      in. Food will be prepared by a Chef knowledgeable in the SCD and whole food diets. Recipes
      will be predetermined and families will be able to decide food for patient based upon menus.
      Patients will receive one-on-one guidance by a Seattle Children's Dietician trained in the
      SCD during each visit. Prior to each visit patient will fill out a 3 day nutrition log which
      will be reviewed by the dietician during the clinic visit.

      Follow-up: Each study subject will have clinical follow-up at 2 weeks, 4 weeks, 8 weeks and
      12weeks. Standardized questionnaires, including the Pediatric Crohn's disease activity index
      (PCDAI) will be completed during each study visit. Information about tabulating the PCDAI
      scores, is listed in Appendix A. In addition patients will have a physical exam and standard
      blood work including CBC, sedimentation rate, C-reactive protein, albumin and stool for
      microbiome analysis at each follow up visit. This stool will be sent to the University of
      Washington (Dr. Sam Miller's lab) for analysis;additional stool samples will be sent to
      Katrine Whitson at UC Irvine for protein analysis. Stool calprotectin will additionally be
      done at week 4 and 12. Vitamin D level will be measured at week 12. Finally, all patients
      will meet with the nutritionist at each visit who will complete a thorough diet review. Any
      questions about the SCD will be addressed at each visit.

      All study related information will be stored in the RedCap database. Participant data for the
      study will be stored electronically in the REDCap platform. The REDCap platform is managed by
      the Institute for Clinical and Translational Science at the University of Washington. Only
      IRB approved research team members will have access to the REDCap data platform. Each team
      member will be granted access to the REDCap data system through a secure login. The
      information about each participant will be de-identified using a unique study code. Some
      personal information such as date of birth will be stored in RedCap.

      Microbiome:

      Some stool from the participants at screening, week 2, 4, 8 and 12 will be stored for
      microbiome analysis. The samples will be stored at Seattle Children's Hospital in the
      Clinical Research Center lab in the -80 freezer. These samples will be sent to the University
      of Washington for microbiome analysis and storage on an as necessary basis. Each of these
      samples will be de-identified and labeled with a unique study code and visit number. Consent
      for storage will be part of the Informed Consent process.
    

Intervention name(s): Traditional SCD Diet; Modified SCD Diet; Whole foods diet
Intervention type(s): Other; Other; Other
Intervention description(s): 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; Food components of the traditional SCD with the addition of rice and oats.; A whole foods diet with removal of processed foods. Removal of corn, wheat, sugar and milk are also apart of this dietary regime.
Other intervention name(s): SCD; Modified SCD
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Specific Carbohydrate Diet; Diet; Nutrition