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

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.

Inclusion Criteria:

1. Children and adolescents eight to twenty one years old

2. Diagnosis of Ulcerative colitis or Crohn's Disease made by a primary
gastroenterologist based upon history, physical exam, laboratory/radiological studies
and gastrointestinal histology

3. Mild or moderate disease activity based upon PCDAI score (10-45) or PUCAI score
(10-60)

4. Parent/guardian and child must be able to comprehend the consent and assent

5. Parent/guardian and participant must be able to attend study visits at baseline, and
weeks +2, +4, +8, +12.

6. Patient must not have medication changes for his/her inflammatory bowel disease
medications for at least 1 months, unless medically necessary.

Exclusion Criteria:

1. Severe disease with PCDAI >45 or PUCAI >60

2. Active or history of intraabdominal abscess, intraabdominal fistula, stricturing
Crohn's disease

3. Other serious medical conditions such as neurological, liver, kidney, autoimmune or
systemic disease.

4. Has begun TNF inhibitors within two months prior to study

5. Has had change of maintenance medication within the last month

6. Tobacco, alcohol or illicit drug abuse

7. Pregnant subject recipients will be excluded