Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of 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.
Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease
Crohn Disease diet specific carbohydrate diet Mediterranean style diet randomized controlled trial
You can join if…
Open to people ages 18 years and up
- 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
You CAN'T join if...
- 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.
- UCSF Colitis and Crohn's Disease Center accepting new patients
San Francisco, California, 94115, United States
- Virginia Mason Medical Center accepting new patients
Seattle, Washington, 98101, United States
- Minnesota Gastroenterology, P.A accepting new patients
Plymouth, Minnesota, 55446, United States
- NorthShore University HealthSystem accepting new patients
Evanston, Illinois, 60201, United States
- Indiana University Health University Hospital accepting new patients
Indianapolis, Indiana, 46202, United States
- Vanderbilt University Medical Center accepting new patients
Nashville, Tennessee, 37232, United States
- University of Cincinnati accepting new patients
Cincinnati, Ohio, 45267, United States
- University of Michigan accepting new patients
Ann Arbor, Michigan, 48109, United States
- Clinical Research Institute of Michigan accepting new patients
Chesterfield, Michigan, 48047, United States
- University Hospitals Cleveland Medical Center accepting new patients
Cleveland, Ohio, 44106, United States
- University of Pittsburgh Medical Center accepting new patients
Pittsburgh, Pennsylvania, 15213, United States
- Wake Forest Baptist Medical Center accepting new patients
Winston-Salem, North Carolina, 27157, United States
- The University of North Carolina accepting new patients
Chapel Hill, North Carolina, 27599, United States
- University of Maryland Baltimore accepting new patients
Baltimore, Maryland, 21201, United States
- University of Pennsylvania accepting new patients
Philadelphia, Pennsylvania, 19104, United States
- NYU Langone Medical Center accepting new patients
New York, New York, 10016, United States
- Icahn School of Medicine at Mount Sinai accepting new patients
New York, New York, 10029, United States
- Dartmouth-Hitchcock Medical Center accepting new patients
Lebanon, New Hampshire, 03756, United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03058679.