Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis
Condition: Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

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 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.
    

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 this study. 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, 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: The treatment for this study will be the Specific Carbohydrate diet (SCD).
      Intervention will be based upon standard dietary therapy as well as a nutritional handbook
      developed in the Gastroenterology division. 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. Each patient will receive books on the SCD therapy which will include
      recipes and information about the diet The two books given will include "Breaking the Vicious
      Cycle" by Elaine Gottschall and "Recipes for the Specific Carbohydrate Diet" by Raman Prasad.

      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) or Pediatric Ulcerative colitis activity index (PUCAI) will be completed during each
      study visit. Information about tabulating the PCDAI/PUCAI 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. 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): Specific Carbohydrate diet (SCD)
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's disease and Ulcerative colitis