Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)
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| ClinicalTrials.gov Identifier: NCT03058679 |
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Recruitment Status :
Completed
First Posted : February 23, 2017
Results First Posted : July 21, 2021
Last Update Posted : July 21, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn Disease | Other: Diet | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 197 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease |
| Actual Study Start Date : | September 29, 2017 |
| Actual Primary Completion Date : | March 1, 2020 |
| Actual Study Completion Date : | March 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Specific Carbohydrate Diet
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.
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Other: Diet
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 |
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Active Comparator: Mediterranean Style Diet
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.
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Other: Diet
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 |
- 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
- Percentage of Participants That Reached Clinical Remission at Week 6 [ Time Frame: 6 weeks ]Assessed by the CDAI - CDAI <150
- Percentage of Participants With a Reduction in Systemic Inflammation at Week 6 [ Time Frame: 6 weeks ]reduction in high-sensitivity CRP (hsCRP) to <5 mg/L and >50% reduction from screening among those with screening hsCRP >5mg/L
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
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Currently participating in another clinical trial of a drug to treat Inflammatory Bowel Disease (IBD) or a dietary therapy for any indication.
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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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058679
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| Principal Investigator: | James D Lewis, MD, MSCE | University of Pennsylvania |
Documents provided by University of Pennsylvania:
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT03058679 |
| Other Study ID Numbers: |
825907 |
| First Posted: | February 23, 2017 Key Record Dates |
| Results First Posted: | July 21, 2021 |
| Last Update Posted: | July 21, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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diet specific carbohydrate diet Mediterranean style diet randomized controlled trial |
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |