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Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease (SCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749813
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
Jennifer Burgis, Stanford University

Brief Summary:
This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease.

Condition or disease
Crohn's Disease

Detailed Description:

Patients will be seen in clinic at new diagnosis of Crohn's disease or a flare of existing disease. Potential subjects will be screened with for eligibility, followed by a baseline assessment by the clinic provider. Subjects who wish to participate will undergo further discussion with one of the study staff. At enrollment, a member of the study staff will explain the study to the prospective participant (for consent and/or assent, if applicable given patient's age).

The SCD will be started in addition to previous maintenance medication therapy or with short course of corticosteroids 1-2mg/kg/day (up to 60mg maximum). Steroid induction based on clinical need.

We anticipate improvement in clinical symptoms, laboratory values and/or a decline in PCDAI of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients) after 4 weeks. Patients who do not reach remission by 4 weeks will be excluded from the study. Patients who require additional medications for disease control will be excluded from the study.

Patients will be seen in clinic at diagnosis, 2 weeks (if required by clinical symptoms), 1 month, 3 months and 6 months.

Assessment at initial enrollment and at all follow-up visits includes:

  1. History of symptoms
  2. Physical exam including height, weight, BMI, Tanner staging
  3. Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or the Crohn's Disease Activity Index (CDAI) score for adult patients.
  4. Dietary assessment and nutritional counseling
  5. Completion of validated quality of life measurement (IMPACT III for pediatric patients and SIBDQ in adult patients)
  6. Adverse event monitoring (record of symptoms and review of laboratory surveillance)
  7. Laboratory assessment including: CBC with differential, basic metabolic panel, liver function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
  8. Serum sample for cytokine studies
  9. Stool studies for microbiota studies

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease
Study Start Date : April 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Primary Outcome Measures :
  1. Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease [ Time Frame: 1 year ]
    The primary end point of the study is the proportion of patients achieving steroid free remission at 6 months

Biospecimen Retention:   Samples With DNA
Blood and stool

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children under 18 Adult

Inclusion Criteria:

  • Adult or pediatric patients presenting with a new diagnosis or flare of existing Crohn's disease based on standard diagnostic criteria including: clinical symptoms, laboratory parameters, disease activity indices (Pediatric Crohn's Disease Activity Index (PCDAI) for patients <19years and Crohn's Disease Activity Index (CDAI) for patients >19years), pathology from upper endoscopy/colonoscopy and imaging studies.

Exclusion Criteria:)

  • Pregnancy
  • Other autoimmune conditions including celiac disease, rheumatoid arthritis, multiple sclerosis
  • Otherwise immunosuppressed patients including HIV and prior organ transplant
  • Patients diagnosed with ulcerative colitis or indeterminate colitis
  • Active tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749813

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United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
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Principal Investigator: Ken Cox, MD Stanford University Medical
Principal Investigator: Shamita Shah, MD Stanford University Medicial
Principal Investigator: Jennifer Burgis, MD Stanford University Medical
Additional Information:
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Responsible Party: Jennifer Burgis, Principle Investigator, Stanford University Identifier: NCT01749813    
Other Study ID Numbers: 23031
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018
Keywords provided by Jennifer Burgis, Stanford University:
Carbohydrate Specific Diet
Crohn's Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases