Title of Study
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)
Phase of study
- Age ≥18
- Documented diagnosis of Crohn's disease
- sCDAI score >175
- Active inflammation documented by a FCP concentration >250ug/g or high sensitivity C-reactive protein (hs-CRP)>5 mg/L measured at screening.
- 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
- 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 randomization
- Start or change dose of anti-TNF agents (including infliximab, adalimumab, certolizumab pegol, golimumab) or ustekinumab within 8 weeks prior to randomization
- Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day prednisone or equivalent*
- 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 nuts
- 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 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.
The DINE-CD study seeks to compare the efficacy of two different dietary strategies to reduce symptoms and inflammation in Crohn's disease. The two diets being studied are the Mediterranean style diet and the Specific Carbohydrate Diet (SCD). Participants will be assigned to one of the two diets for a 12 week period. During the first six weeks, participants will be provided with all of their food. For the last six weeks, participants will be asked to follow the diet on their own (with the option to purchase some or all of their meals from the same vendor providing food during the first six weeks). During the duration of the study, participants will complete three study visits at one of the study sites located throughout the United States.
Description of Treatment or Intervention (Mechanism of Action)
- A Mediterranean style diet is rich in fiber and plant-based food. It also includes olive oil, low fat dairy, herbs, and spices. Poultry, eggs, cheese, and yogurt are eaten in moderation, and red meat is eaten rarely. Research has shown that a Mediterranean style diet has numerous health benefits, including reducing the risk of heart disease and lowering cholesterol as well as reducing incidence of cancer and Parkinson's and Alzheimer's diseases.
- SCD eliminates refined/processed foods and many type of carbohydrates as well as soy, lactose, sucrose, and grains, and certain vegetables such as potatoes, okra and corn. This diet can be low in certain nutrients, such as B vitamins, calcium, vitamin D, and vitamin E.
Patient Participation Requirements
18 years old or older, mild to moderate Crohn's disease, stable dose of medications prior to screening.
Possible Risks & Side Effects
Your Crohn's Disease may not get better or may get worse while on study. Additionally, with any research study, a breach of confidentiality may occur.