Crohn DiseaseDINE-CDNCT03058679
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
A study testing Diet in people with Crohn Disease, run by University of Pennsylvania at 35 sites in United States.
Trial summary
This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 35 sitesUnited States
- Study dates
- 29 Sep 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Documented diagnosis of Crohn's disease
- sCDAI score >175
- Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.
- Access to a computer with internet and the ability to complete daily online surveys
- Capable of providing consent to participate
- Able to receive weekly food shipments delivered every Friday for 6 weeks
Who cannot join
- Pregnancy
- sCDAI >400
- Hospitalized patients
- Anticipated need for surgery within 6 weeks of randomization
- Use of the Specific Carbohydrate Diet within 4 weeks of screening
- Start or change*** dose of thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab within 12 weeks prior to screening
Show all 24Show fewer
- Start or change*** dose of anti-tumor necrosis factor (TNF) agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab within 8 weeks prior to screening.
- Start or change in dose of any 5-aminosalicylic acid (5-ASA) medications within 2 weeks of screening.
- Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
- Use of antibiotics (other than topical formulations) for any reason within 2 weeks prior to screening
- Known symptomatic intestinal stricture.
- Presence of an ostomy
- Baseline stool frequency >4 bowel movements/day when well
- BMI <16
- BMI ≥40
- Celiac disease
- Documented C difficile colitis within four weeks of screening
- Diabetes Mellitus requiring medication
- Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care)
- Known allergy to tree nuts or peanuts
- Other conditions that would be a contraindication to any of the study diets or preclude the participant from completing the study.
- Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication.
- Patients may continue these medications at stable dose for the first six weeks and budesonide may be used at any dose. After the 6th week in the study, patients may taper their steroid dose. The study will provide a recommended taper schedule.
- Loading/induction doses of biologic type medication will be considered a stable doses. ***Exception for treatment failures: if a subject is determined to fail on any of the following standard lines of treatment at the treating investigator's discretion, subjects may screen for study intervention based upon the following wash out periods: 4 weeks for thiopurine and methotrexate and 8 weeks for natalizumab, vedolizumab, anti-TNF, or ustekinumab.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Emory University
Atlanta, Georgia, 30322
Atlanta Gastroenterology
Atlanta, Georgia, 30342
University of Maryland Baltimore
Baltimore, Maryland, 21201
Boston Children's Hospital
Boston, Massachusetts, 02115
The University of North Carolina
Chapel Hill, North Carolina, 27599
Atrium Health (formerly Carolinas HealthCare System)
Charlotte, North Carolina, 28203
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
University of Chicago
Chicago, Illinois, 60614
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio State University - Wexner Medical Center
Columbus, Ohio, 43210
University of Colorado Denver
Denver, Colorado, 80204
NorthShore University HealthSystem
Evanston, Illinois, 60201
Northwestern University
Evanston, Illinois, 60208
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
The University of Louisville
Louisville, Kentucky, 40202
University of Wisconsin-Madison
Madison, Wisconsin, 53706
The University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Langone Medical Center
New York, New York, 10016
Weill Cornell - NewYork Presbyterian
New York, New York, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lenox Hill Hospital
New York, New York, 10075
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Minnesota Gastroenterology, P.A
Plymouth, Minnesota, 55446
Lifespan Health System
Providence, Rhode Island, 02903
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
UCSF Colitis and Crohn's Disease Center
San Francisco, California, 94115
Virginia Mason Medical Center
Seattle, Washington, 98101
Troy Gastroenterology
Troy, Michigan, 48092
University of Arizona
Tucson, Arizona, 85724
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.
Read the detailed description
This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD.
The study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score >175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration >250mcg/g or high sensitivity C-reactive protein (CRP) >7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score >4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation.
Eligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again
- Conditions
- Crohn Disease
- Being tested
- Diet
- Keywords
- diet, specific carbohydrate diet, Mediterranean style diet, randomized controlled trial
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Specific Carbohydrate Diet | Experimental | For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the SCD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Participants assigned to the SCD received a three3-day starter diet as recommended in Breaking the Vicious Cycle. Meals were designed to be heated in an oven or microwave. No other preparation was required. Receives: Other: Diet |
| Mediterranean Style Diet | Active comparator | For the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the MD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Meals were designed to be heated in an oven or microwave. No other preparation was required. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Achieved Symptomatic Remission at Week 6
Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI <150 in the absence of initiation or increase of any CD medications
Measured: 6 weeks
Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6
reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC >250 μg/g
Measured: 6 weeks
Secondary outcomes (2)
Percentage of Participants That Reached Clinical Remission at Week 6
Assessed by the CDAI - CDAI <150
Measured: 6 weeks
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
reduction in high-sensitivity CRP (hsCRP) to <5 mg/L and >50% reduction from screening among those with screening hsCRP >5mg/L
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start29 Sep 2017
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- James D Lewis, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058679
- Sponsor's protocol ID
- 825907
- Acronym
- DINE-CD
- Status last verified
- Jun 2021
- First submitted
- 16 Feb 2017
- Last updated
- 21 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27.
PubMed 34052278
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT03058679
- Acronym / sponsor ID
- DINE-CD / 825907
- Conditions
- Crohn Disease
- Keywords
- diet, specific carbohydrate diet, Mediterranean style diet, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation, University of North Carolina, Chapel Hill
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.
Detailed description
This study tested whether the SCD is superior to a MSD for managing symptoms and reducing inflammatory markers in patients with CD.
The study was designed to include 194 patients with CD who have 1) active symptoms defined by a short Crohn's Disease Activity Index (sCDAI) score >175. Although the initial plan was to also require that all patients have active inflammation documented by a fecal calprotectin (FCP) concentration >250mcg/g or high sensitivity C-reactive protein (CRP) >7 mg/L or ulceration of the small bowel and/or colon consistent with an SES-CD score >4 as documented in routine clinical practice within 4 weeks of screening, a decision was made early in the recruitment period to enroll all patients with CD with sCDAI>175 regardless of the results of the tests for inflammatory markers and to perform subgroup analyses of those with and without evidence of inflammation.
Eligible participants were randomly assigned to follow one of the diets in a 1:1 ratio. Participants were provided with 3 meals and 2 snacks each day for a period of 6 weeks. The meals and snacks were prepared by the food vendor, Healthy Chef Creations, and were delivered directly to the participant's home once per week. Participants in both groups were also provided with instructions on how to follow the diets on their own. Participants reported their symptoms through an electronic diary and provided stool samples for FCP measurement and blood for CRP measurement at weeks 0, 6 and 12. The primary and secondary outcomes were assessed at week 6. Following week 6, participants were able to pay out of pocket to purchase food from Healthy Chef Creations and/or could attempt to follow their assigned diet completely on their own. At week 12, in addition to the primary and secondary outcomes assessed again
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Carbohydrate Diet | Experimental | Other: DietFor the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the SCD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Participants assigned to the SCD received a three3-day starter diet as recommended in Breaking the Vicious Cycle. Meals were designed to be heated in an oven or microwave. No other preparation was required. |
| Mediterranean Style Diet | Active comparator | Other: DietFor the first six 6 weeks of the trial, participants received a weekly delivery of prepared meals compliant with the MD (breakfast, lunch, dinner, and two 2 snacks per day). Meals were prepared by Healthy Chef Creations (Orlando, FL) based on menus developed by the food vendor in consultation with study dietitians. Meals were designed to be heated in an oven or microwave. No other preparation was required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18
- Documented diagnosis of Crohn's disease
- sCDAI score >175
- Documentation of receipt of a baseline stool sample by the data coordinating center and hsCRP.
- Access to a computer with internet and the ability to complete daily online surveys
Key exclusion criteria (24 listed)
- Pregnancy
- sCDAI >400
- Hospitalized patients
- Anticipated need for surgery within 6 weeks of randomization
- Use of the Specific Carbohydrate Diet within 4 weeks of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietfood for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks | Other | Mediterranean Style Diet, Specific Carbohydrate Diet |
Primary outcome
Percentage of Participants That Achieved Symptomatic Remission at Week 6
Time frame: 6 weeks
Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI <150 in the absence of initiation or increase of any CD medications
Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6
Time frame: 6 weeks
reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC >250 μg/g
2 secondary outcomes
Percentage of Participants That Reached Clinical Remission at Week 6
Time frame: 6 weeks
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34052278Lewis JD, Sandler RS, Brotherton C, Brensinger C, Li H, Kappelman MD, Daniel SG, Bittinger K, Albenberg L, Valentine JF, Hanson JS, Suskind DL, Meyer A, Compher CW, Bewtra M, Saxena A, Dobes A, Cohen BL, Flynn AD, Fischer M, Saha S, Swaminath A, Yacyshyn B, Scherl E, Horst S, Curtis JR, Braly K, Nessel L, McCauley M, McKeever L, Herfarth H; DINE-CD Study Group. A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults With Crohn's Disease. Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27.
- Individual participant dataSharing planned: No
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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.
James D Lewis, MD, MSCE principal investigator
University of Pennsylvania
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Crohn Disease, run by University of Pennsylvania at 35 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 7 inclusion and 24 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants That Achieved Symptomatic Remission at Week 6 (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03058679, which also lists 1 linked publication.
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 21 Jul 2021.