Crohn's DiseaseSCDNCT01749813
Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease
An observational study of Crohn's Disease, run by Stanford University at 2 sites in United States.
Trial summary
This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Crohn's Disease
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 18 Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University Medical Center
Palo Alto, California, 94304
Stanford
Palo Alto, California, 94304
About this study
This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with Crohn's disease.
Read the 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:
- History of symptoms
- Physical exam including height, weight, BMI, Tanner staging
- Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or the Crohn's Disease Activity Index (CDAI) score for adult patients.
- Dietary assessment and nutritional counseling
- Completion of validated quality of life measurement (IMPACT III for pediatric patients and SIBDQ in adult patients)
- Adverse event monitoring (record of symptoms and review of laboratory surveillance)
- Laboratory assessment including: CBC with differential, basic metabolic panel, liver function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
- Serum sample for cytokine studies
- Stool studies for microbiota studies
- Conditions
- Crohn's Disease
- Keywords
- Carbohydrate Specific Diet, Crohn's Disease, Immunomodulators
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Burgis, Stanford University
- Investigators
- Ken Cox, MD, Principal investigator, Stanford University MedicalShamita Shah, MD, Principal investigator, Stanford University MedicialJennifer Burgis, MD, Principal investigator, Stanford University Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749813
- Sponsor's protocol ID
- 23031
- Acronym
- SCD
- Status last verified
- Feb 2018
- First submitted
- 12 Dec 2012
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease
- ClinicalTrials.gov ID
- NCT01749813
- Acronym / sponsor ID
- SCD / 23031
- Conditions
- Crohn's Disease
- Keywords
- Carbohydrate Specific Diet, Crohn's Disease, Immunomodulators
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether the specific carbohydrate diet (SCD) can maintain clinical remission in pediatric and adult patients with 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:
- History of symptoms
- Physical exam including height, weight, BMI, Tanner staging
- Calculation of Pediatric Crohn's Disease Activity Index (PCDAI) for pediatric patients or the Crohn's Disease Activity Index (CDAI) score for adult patients.
- Dietary assessment and nutritional counseling
- Completion of validated quality of life measurement (IMPACT III for pediatric patients and SIBDQ in adult patients)
- Adverse event monitoring (record of symptoms and review of laboratory surveillance)
- Laboratory assessment including: CBC with differential, basic metabolic panel, liver function tests, albumin, ESR, CRP, stool calprotectin and stool lactoferrin
- Serum sample for cytokine studies
- Stool studies for microbiota studies
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Specific Carbohydrate Diet in Crohn's DiseaseLink provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Cox, MD principal investigator
Stanford University Medical
Shamita Shah, MD principal investigator
Stanford University Medicial
Jennifer Burgis, MD principal investigator
Stanford University Medical
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Carbohydrate Diet as Maintenance Therapy in Crohn's Disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.