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

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ClinicalTrials.gov Identifier: NCT02213835
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE August 4, 2014
First Posted Date  ICMJE August 12, 2014
Last Update Posted Date May 24, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Change in Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index at baseline and 12 weeks [ Time Frame: 12 Week ]
Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index are validated measures of disease activity for pediatric Crohn's disease and ulcerative colitis respectively.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02213835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Change of common Laboratory measures including Complete Blood Count, sedimentation rate, C-Reactive Protein, stool Calprotectin at baseline and 12 weeks [ Time Frame: 12 weeks ]
Validated clinical laboratory tests preformed at an accredited laboratory
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
Change of common Laboratory measures including Complete Blood Count, sedimentation rate, C-Reactive Protein, stool Calprotectin at baseline and 12 weeks [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: May 22, 2019)
Stool Microbiome Analysis from baseline and 12 weeks [ Time Frame: 12 Weeks ]
Changes in fecal microbiome as defined by species types and percent of total microbiome will be measured using Metagenomic Phylogenetic Analysis (MetaPhlAn)
Original Other Pre-specified Outcome Measures
 (submitted: August 7, 2014)
Stool Microbiome Analysis from baseline and 12 weeks [ Time Frame: 12 Weeks ]
 
Descriptive Information
Brief Title  ICMJE Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis
Official Title  ICMJE Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn's Disease
  • Ulcerative Colitis
Intervention  ICMJE Other: Specific Carbohydrate diet (SCD)
Study Arms  ICMJE Experimental: Specific Carbohydrate diet (SCD)
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.
Intervention: Other: Specific Carbohydrate diet (SCD)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
10
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213835
Other Study ID Numbers  ICMJE SCD001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Not discussed
Responsible Party David Suskind, Seattle Children's Hospital
Study Sponsor  ICMJE David Suskind
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David L Suskind, MD Seattle Children's Hospital and The University of Washington
PRS Account Seattle Children's Hospital
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP