Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

Completed · Not applicable

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT03058679

Run by

University of Pennsylvania

People needed

197

Starts

2017-09-29

Expected to finish

2020-03-01

Last updated by the study team

2021-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• UCSF Colitis and Crohn's Disease Center — San Francisco, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Emory University — Atlanta, Georgia, United States
• Atlanta Gastroenterology — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Northwestern University — Evanston, Illinois, United States
• Indiana University Health University Hospital — Indianapolis, Indiana, United States
• The University of Louisville — Louisville, Kentucky, United States
• University of Maryland Baltimore — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Clinical Research Institute of Michigan — Chesterfield, Michigan, United States
• Troy Gastroenterology — Troy, Michigan, United States
• The University of Minnesota — Minneapolis, Minnesota, United States
• Minnesota Gastroenterology, P.A — Plymouth, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• NYU Langone Medical Center — New York, New York, United States
• Weill Cornell - NewYork Presbyterian — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• The University of North Carolina — Chapel Hill, North Carolina, United States
• Atrium Health (formerly Carolinas HealthCare System) — Charlotte, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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