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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Burgis, Stanford University
ClinicalTrials.gov Identifier:
NCT01749813
First received: December 12, 2012
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

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


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children under 18 Adult

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749813

Locations
United States, California
Stanford
Palo Alto, California, United States, 94304
Stanford University Medical Center
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Ken Cox, MD Stanford University Medical
Principal Investigator: Shamita Shah, MD Stanford University Medicial
Principal Investigator: Jennifer Burgis, MD Stanford University Medical
  More Information

Additional Information:
No publications provided

Responsible Party: Jennifer Burgis, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01749813     History of Changes
Other Study ID Numbers: 23031
Study First Received: December 12, 2012
Last Updated: May 28, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Stanford University:
Carbohydrate Specific Diet
Crohn's Disease
Immunomodulators

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 01, 2015