Nutritional Therapy Study in Pediatric Crohn's Disease
|ClinicalTrials.gov Identifier: NCT02610101|
Recruitment Status : Enrolling by invitation
First Posted : November 20, 2015
Last Update Posted : May 30, 2018
The goal of any research study is to answer questions. 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?
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Other: Traditional SCD Diet Other: Modified SCD Diet Other: Whole foods diet||Not Applicable|
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.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Blinded, Nutritional Therapy Study, Using a Modified Specific Carbohydrate Diet in Pediatric Crohn's Disease|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Traditional SCD Diet
7 subjects will be randomized to a traditional SCD diet
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 Name: SCD
Active Comparator: Modified SCD Diet
7 subjects will be randomized to a "modified SCD diet", which includes oatmeal and rice
Other: Modified SCD Diet
Food components of the traditional SCD with the addition of rice and oats.
Other Name: Modified SCD
Active Comparator: Whole Foods Diet
7 subjects will be randomized to a" Whole foods diet" without added sugars
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.
- Change in Pediatric Crohn's Disease Activity Index [ Time Frame: 12 weeks ]Activity Index is a validated form of measurement for disease activity
- Fecal Microbiome Analysis [ 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)
- Change in C-reactive protein at Baseline and 12 weeks [ Time Frame: 12 weeks ]
- Change in Calprotectin at Baseline and 12 weeks [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610101
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|