NCT01749813

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

3.1 years

First QC Date

December 12, 2012

Last Update Submit

February 7, 2018

Conditions

Crohn's Disease

Keywords

Carbohydrate Specific DietCrohn's DiseaseImmunomodulators

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children under 18 Adult

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Stanford

Palo Alto, California, 94304, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Ken Cox, MD

    Stanford University Medical

    PRINCIPAL INVESTIGATOR

  • Shamita Shah, MD

    Stanford University Medicial

    PRINCIPAL INVESTIGATOR

  • Jennifer Burgis, MD

    Stanford University Medical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 17, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations

US(2)