Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease

Crohn's Disease Clinical Trial

— SCD  

Official title:

Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749813
• Other study ID #: 23031
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: February 7, 2018
• Start date: April 2012
• Est. completion date: May 2015

Study information

• Verified date: February 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
United States	Stanford	Palo Alto	California
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease	The primary end point of the study is the proportion of patients achieving steroid free remission at 6 months	1 year

External Links

•   Specific Carbohydrate Diet in Crohn's Disease