<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02213835</url>
  </required_header>
  <id_info>
    <org_study_id>SCD001</org_study_id>
    <nct_id>NCT02213835</nct_id>
  </id_info>
  <brief_title>Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis</brief_title>
  <acronym>SCD</acronym>
  <official_title>Treatment With the Specific Carbohydrate Diet for Children With Active Crohns Disease and Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Suskind</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the tolerability and potential efficacy of dietary&#xD;
      therapy, the Specific Carbohydrate Diet (SCD), in pediatric patients with Crohn's disease&#xD;
      (CD) and Ulcerative Colitis (UC). This is a single center, open labelled study designed to&#xD;
      determine tolerability, preliminary safety and potential efficacy in pediatric patients with&#xD;
      CD and UC. The study patients will be recruited from Seattle Children's GI clinic. the&#xD;
      investigators will enroll 10 patients with mild to moderate CD (defined as PCDAI score of&#xD;
      10-29) or Ulcerative colitis (PUCAI 10-60) ages 8 to 21 years. Each patient will be in the&#xD;
      study for approximately 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten patients with CD or UC with mild or moderate disease activity as defined by Pediatric&#xD;
      Crohn's disease activity index (PCDAI score of 10-29 or PUCAI of 10 - 60) aged 8 -21 years&#xD;
      will enroll into this study. Each patient will receive an initial evaluation including a&#xD;
      physical exam, medication review, nutritional guidance and post treatment evaluations.&#xD;
&#xD;
      Initial evaluation: Study subject recipient will have the following lab tests including CBC&#xD;
      with differential &amp; platelets, a c-reactive protein, sedimentation rate, an albumin, vitamin&#xD;
      D level, a stool study for c. difficile, for bacterial culture and ova and parasite, stool&#xD;
      calprotectin and microbiome. Additionally, the investigators will complete a physical exam&#xD;
      and document their current medications. The study nutritionist will complete a thorough diet&#xD;
      history.&#xD;
&#xD;
      Treatment: The treatment for this study will be the Specific Carbohydrate diet (SCD).&#xD;
      Intervention will be based upon standard dietary therapy as well as a nutritional handbook&#xD;
      developed in the Gastroenterology division. Patients will receive one-on-one guidance by a&#xD;
      Seattle Children's Dietician trained in the SCD during each visit. Prior to each visit&#xD;
      patient will fill out a 3 day nutrition log which will be reviewed by the dietician during&#xD;
      the clinic visit. Each patient will receive books on the SCD therapy which will include&#xD;
      recipes and information about the diet The two books given will include &quot;Breaking the Vicious&#xD;
      Cycle&quot; by Elaine Gottschall and &quot;Recipes for the Specific Carbohydrate Diet&quot; by Raman Prasad.&#xD;
&#xD;
      Follow-up: Each study subject will have clinical follow-up at 2 weeks, 4 weeks, 8 weeks and&#xD;
      12weeks. Standardized questionnaires, including the Pediatric Crohn's disease activity index&#xD;
      (PCDAI) or Pediatric Ulcerative colitis activity index (PUCAI) will be completed during each&#xD;
      study visit. Information about tabulating the PCDAI/PUCAI scores is listed in Appendix A. In&#xD;
      addition patients will have a physical exam and standard blood work including CBC,&#xD;
      sedimentation rate, C-reactive protein, albumin and stool for microbiome analysis at each&#xD;
      follow up visit. This stool will be sent to the University of Washington (Dr. Sam Miller's&#xD;
      lab) for analysis. Stool calprotectin will additionally be done at week 4 and 12. Vitamin D&#xD;
      level will be measured at week 12. Finally, all patients will meet with the nutritionist at&#xD;
      each visit who will complete a thorough diet review. Any questions about the SCD will be&#xD;
      addressed at each visit.&#xD;
&#xD;
      All study related information will be stored in the RedCap database. Participant data for the&#xD;
      study will be stored electronically in the REDCap platform. The REDCap platform is managed by&#xD;
      the Institute for Clinical and Translational Science at the University of Washington. Only&#xD;
      IRB approved research team members will have access to the REDCap data platform. Each team&#xD;
      member will be granted access to the REDCap data system through a secure login. The&#xD;
      information about each participant will be de-identified using a unique study code. Some&#xD;
      personal information such as date of birth will be stored in RedCap.&#xD;
&#xD;
      Microbiome:&#xD;
&#xD;
      Some stool from the participants at screening, week 2, 4, 8 and 12 will be stored for&#xD;
      microbiome analysis. The samples will be stored at Seattle Children's Hospital in the&#xD;
      Clinical Research Center lab in the -80 freezer. These samples will be sent to the University&#xD;
      of Washington for microbiome analysis and storage on an as necessary basis. Each of these&#xD;
      samples will be de-identified and labeled with a unique study code and visit number. Consent&#xD;
      for storage will be part of the Informed Consent process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index at baseline and 12 weeks</measure>
    <time_frame>12 Week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of common Laboratory measures including Complete Blood Count, sedimentation rate, C-Reactive Protein, stool Calprotectin at baseline and 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
    <description>Validated clinical laboratory tests preformed at an accredited laboratory</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stool Microbiome Analysis from baseline and 12 weeks</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Changes in fecal microbiome as defined by species types and percent of total microbiome will be measured using Metagenomic Phylogenetic Analysis (MetaPhlAn)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Crohn's Disease</condition>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>Specific Carbohydrate diet (SCD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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 &quot;Breaking the Vicious Cycle&quot; by Elaine Gottschall and &quot;Recipes for the Specific Carbohydrate Diet&quot; by Raman Prasad.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specific Carbohydrate diet (SCD)</intervention_name>
    <arm_group_label>Specific Carbohydrate diet (SCD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children and adolescents eight to twenty one years old&#xD;
&#xD;
          2. Diagnosis of Ulcerative colitis or Crohn's Disease made by a primary&#xD;
             gastroenterologist based upon history, physical exam, laboratory/radiological studies&#xD;
             and gastrointestinal histology&#xD;
&#xD;
          3. Mild or moderate disease activity based upon PCDAI score (10-45) or PUCAI score&#xD;
             (10-60)&#xD;
&#xD;
          4. Parent/guardian and child must be able to comprehend the consent and assent&#xD;
&#xD;
          5. Parent/guardian and participant must be able to attend study visits at baseline, and&#xD;
             weeks +2, +4, +8, +12.&#xD;
&#xD;
          6. Patient must not have medication changes for his/her inflammatory bowel disease&#xD;
             medications for at least 1 months, unless medically necessary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe disease with PCDAI &gt;45 or PUCAI &gt;60&#xD;
&#xD;
          2. Active or history of intraabdominal abscess, intraabdominal fistula, stricturing&#xD;
             Crohn's disease&#xD;
&#xD;
          3. Other serious medical conditions such as neurological, liver, kidney, autoimmune or&#xD;
             systemic disease.&#xD;
&#xD;
          4. Has begun TNF inhibitors within two months prior to study&#xD;
&#xD;
          5. Has had change of maintenance medication within the last month&#xD;
&#xD;
          6. Tobacco, alcohol or illicit drug abuse&#xD;
&#xD;
          7. Pregnant subject recipients will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David L Suskind, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Hospital and The University of Washington</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24048168</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>David Suskind</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Crohn's disease and Ulcerative colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not discussed</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02213835
org study id: SCD001
nct id: NCT02213835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Pediatric Crohn's disease Activity Index/Pediatric Ulcerative Colitis Activity Index at baseline and 12 weeks
time frame: 12 Week
description: 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.
measure: 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
description: Validated clinical laboratory tests preformed at an accredited laboratory
measure: Stool Microbiome Analysis from baseline and 12 weeks
time frame: 12 Weeks
description: Changes in fecal microbiome as defined by species types and percent of total microbiome will be measured using Metagenomic Phylogenetic Analysis (MetaPhlAn)
arm group label: Specific Carbohydrate diet (SCD)
arm group type: Experimental
description: 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 type: Other
intervention name: Specific Carbohydrate diet (SCD)
arm group label: Specific Carbohydrate diet (SCD)
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: No
last name: David L Suskind, MD
role: Principal Investigator
affiliation: Seattle Children's Hospital and The University of Washington
facility: 
country: United States
citation: 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.
PMID: 24048168
responsible party type: Sponsor-Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: David Suskind
investigator title: Professor of Pediatrics
mesh term: Crohn Disease
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No
ipd description: Not discussed