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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01749813
First received: December 12, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease in comparison to standard of care with immune modulating therapy.


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 1 year


Biospecimen Retention:   Samples With DNA

Blood and stool


Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 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).

Standard 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 thiopurine metabolites (if indicated at the 2 month visit)
  8. Serum sample for lymphocyte and cytokine studies (Nadeau lab)
  9. Stool studies for microbiota studies (Relman lab)

At enrollment, additional laboratory value includes:

  1. Quantiferon TB test or PPD placement
  2. Varicella IgG (if no known history of varicella)
  3. IBD-7 serology
  4. TPMT enzyme (for individualized starting dose of thiopurines)
  5. Stool culture and Clostridium difficile toxin PCR

All patients will receive initial therapy, known as induction therapy, with corticosteroids 1-2mg/kg/day (up to 60mg maximum) for 2 weeks. At 2 weeks, the patients will be evaluated for improved symptoms and/or a decline in PCDAI of 12.5 points (pediatric patients) or decline in CDAI of 70 points (adult patients).

Patients responsive to steroids at 2 weeks (as defined above) will choose to follow either the SCD or start an immunomodulator medication (including mercaptopurine, azathioprine or methotrexate after discussion with their physician). Medication doses are based on weight and for thiopurines specifically by enzyme activity level. Patients will not be randomized to the treatment arms. For both treatment arms, once patients reach remission (defined as PCDAI <10 or CDAI <150) they will begin a standard steroid taper over the next 8-12weeks. Patients that do not reach remission by 4 weeks will be excluded from the study.

As is standard of care for patients with Crohn's disease, recommendations will be made for keeping vaccinations up to date including yearly influenza vaccine, ophthalmologic examination and a DEXA scan (if patients require greater than 3 months of chronic steroid therapy) during the next year of followup.

Patients will be seen in clinic at diagnosis, 2 weeks, 1 month, 2 months, 3 months and then every 3 months until a flare of symptoms or one year, whichever comes first. Worsening of symptoms, known as disease flare, is defined as PCDAI score >30 points or CDAI >220 points. The primary endpoint is the proportion of patients in steroid free remission at 1 year, defined as PCDAI <10 points and CDAI <150 points.

  Eligibility

Ages Eligible for Study:   18 Years and older
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
  • Prior medication use including probiotics within last 1 month, biologics (monoclonal or humanized recombinant antibodies) within last 3 months, immunomodulators within last 3 months, antibiotics within last 2 months, steroids or budesonide within last 2 months, start and/or change in dose of 5-ASA or azulfidine in last 2 months
  • 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

Contacts
Contact: Ken Cox, MD (650) 721-2250 kcox@lpch.org
Contact: Jennifer Burgis, MD (650) 725-2531 jburgis@stanford.edu

Locations
United States, California
Stanford Recruiting
Palo Alto, California, United States, 94304
Contact: Ken Cox, MD    650-723-5070    kcox@lpch.org   
Contact: Jennifer Burgis, MD    (650) 725-2531    jburgis@stanford.edu   
Principal Investigator: Ken Cox, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Shamita Shah, MD    650-736-0431    shamita@stanford.edu   
Principal Investigator: Ken Cox, MD         
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact: Jennifer Burgis, MD    650-723-5070    jburgis@stanford.edu   
Contact: Kaylie Nguyen    650) 723-5070    kanguyen@lpch.org   
Principal Investigator: Ken Cox, MD         
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: Stanford University
ClinicalTrials.gov Identifier: NCT01749813     History of Changes
Other Study ID Numbers: 23031
Study First Received: December 12, 2012
Last Updated: April 3, 2014
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
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014