Crohn's DiseaseNCT02610101
Nutritional Therapy Study in Pediatric Crohn's Disease
A study testing Traditional SCD Diet, Modified SCD Diet and Whole foods diet in people with Crohn's Disease, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Traditional SCD Diet, Modified SCD Diet and Whole foods diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents 8 to 21 years old
- Diagnosis of Crohn's Disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology
- Mild or moderate disease activity based upon PCDAI score (10-45)
- Parent/guardian and child must be able to comprehend the consent and assent
- Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12.
- Patient must not have medication changes for his/her inflammatory bowel disease medications for at least 1 months, unless medically necessary.
Who cannot join
- Severe disease with PCDAI >45
- Active or history of intra abdominal abscess, intra abdominal fistula, stricturing Crohn's disease
- Other serious medical conditions such as neurological, liver, kidney, autoimmune or systemic disease.
- Has begun TNF inhibitors within two months prior to study
- Has had change of maintenance medication within the last month
- Tobacco, alcohol or illicit drug abuse
- Pregnant subject recipients will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Blinded, Nutritional Therapy Study, Using a Modified Specific Carbohydrate Diet in Pediatric Crohn's Disease
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:
Read more
- Traditional SCD diet group
- Modified SCD to include oatmeal and rice
- 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?
Read the detailed description
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.
- Conditions
- Crohn's Disease
- Being tested
- Traditional SCD Diet, Modified SCD Diet, Whole foods diet
- Keywords
- Specific Carbohydrate Diet, Diet, Nutrition
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional SCD DietOther
Also called SCD
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
Modified SCD DietOther
Also called Modified SCD
Food components of the traditional SCD with the addition of rice and oats.
Whole foods dietOther
A whole foods diet with removal of processed foods. Removal of corn, wheat, sugar and milk are also apart of this dietary regime.
| Study group | Role | What they receive |
|---|---|---|
| Traditional SCD Diet | Active comparator | 7 subjects will be randomized to a traditional SCD diet Receives: Other: Traditional SCD Diet |
| Modified SCD Diet | Active comparator | 7 subjects will be randomized to a "modified SCD diet", which includes oatmeal and rice Receives: Other: Modified SCD Diet |
| Whole Foods Diet | Active comparator | 7 subjects will be randomized to a" Whole foods diet" without added sugars Receives: Other: Whole foods diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Crohn's Disease Activity Index
Activity Index is a validated form of measurement for disease activity
Measured: 12 weeks
Secondary outcomes (3)
Fecal Microbiome Analysis
Changes in fecal microbiome as defined by species types and percent of total microbiome will be measured using Metagenomic Phylogenetic Analysis (MetaPhlAn)
Measured: 12 weeks
Change in C-reactive protein at Baseline and 12 weeks
Decrease in C-reactive protein (CRP) by Immunorate by Vitros 4600
Measured: 12 weeks
Change in Calprotectin at Baseline and 12 weeks
Decrease in fecal calprotectin by ELISA
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Suskind, Seattle Children's Hospital
- Investigators
- David L Suskind, MD, Principal investigator, Seattle Children's Hospital and The University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610101
- Sponsor's protocol ID
- IRB#15606
- Status last verified
- Apr 2019
- First submitted
- 16 Nov 2015
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Publications
Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103.
PubMed 24048168
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded, Nutritional Therapy Study, Using a Modified Specific Carbohydrate Diet in Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT02610101
- Acronym / sponsor ID
- IRB#15606
- Conditions
- Crohn's Disease
- Keywords
- Specific Carbohydrate Diet, Diet, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Traditional SCD diet group
- Modified SCD to include oatmeal and rice
- 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?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional SCD Diet | Active comparator | Other: Traditional SCD Diet7 subjects will be randomized to a traditional SCD diet |
| Modified SCD Diet | Active comparator | Other: Modified SCD Diet7 subjects will be randomized to a "modified SCD diet", which includes oatmeal and rice |
| Whole Foods Diet | Active comparator | Other: Whole foods diet7 subjects will be randomized to a" Whole foods diet" without added sugars |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children and adolescents 8 to 21 years old
- Diagnosis of Crohn's Disease made by a primary gastroenterologist based upon history, physical exam, laboratory/radiological studies and gastrointestinal histology
- Mild or moderate disease activity based upon PCDAI score (10-45)
- Parent/guardian and child must be able to comprehend the consent and assent
- Parent/guardian and participant must be able to attend study visits at baseline, and weeks +2, +4, +8, +12.
Key exclusion criteria (7 listed)
- Severe disease with PCDAI >45
- Active or history of intra abdominal abscess, intra abdominal fistula, stricturing Crohn's disease
- Other serious medical conditions such as neurological, liver, kidney, autoimmune or systemic disease.
- Has begun TNF inhibitors within two months prior to study
- Has had change of maintenance medication within the last month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional SCD DietAlso: SCDTraditional 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 | Traditional SCD Diet |
| Modified SCD DietAlso: Modified SCDFood components of the traditional SCD with the addition of rice and oats. | Other | Modified SCD Diet |
| Whole foods dietA whole foods diet with removal of processed foods. Removal of corn, wheat, sugar and milk are also apart of this dietary regime. | Other | Whole Foods Diet |
Primary outcome
Change in Pediatric Crohn's Disease Activity Index
Time frame: 12 weeks
Activity Index is a validated form of measurement for disease activity
3 secondary outcomes
Fecal Microbiome Analysis
Time frame: 12 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Background: PubMed 24048168Suskind DL, Wahbeh G, Gregory N, Vendettuoli H, Christie D. Nutritional therapy in pediatric Crohn disease: the specific carbohydrate diet. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):87-91. doi: 10.1097/MPG.0000000000000103.
- Individual participant dataSharing planned: No. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Suskind, MD principal investigator
Seattle Children's Hospital and The University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional SCD Diet, Modified SCD Diet and Whole foods diet in people with Crohn's Disease, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Crohn's Disease Activity Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610101, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.