Nutritional Therapy Study in Pediatric Crohn's Disease
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 12 - 21 |
| Updated: | 6/1/2018 |
| Start Date: | November 2015 |
| End Date: | December 2018 |
A Blinded, Nutritional Therapy Study, Using a Modified Specific Carbohydrate Diet in Pediatric Crohn's Disease
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?
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?
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.
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.
Inclusion Criteria:
1. Children and adolescents 8 to 21 years old
2. Diagnosis of 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)
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
2. Active or history of intra abdominal abscess, intra abdominal 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
We found this trial at
1
site
4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: David Suskind, MD
Phone: 206-987-0055
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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