N/A
N=191
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
Crohn Disease
Bottom Line
View on ClinicalTrials.gov: NCT03058679 ↗Enrolled (actual)
191
Serious AEs
4.2%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Participants That Achieved Symptomatic Remission at Week 6 — 40; 46 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Achieved Symptomatic Remission at Week 6 |
40; 46 | — |
| PRIMARY 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 |
4; 8 | — |
| SECONDARY Percentage of Participants That Reached Clinical Remission at Week 6 |
44; 48 | — |
| SECONDARY Percentage of Participants With a Reduction in Systemic Inflammation at Week 6 |
1; 2 | — |
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. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease.
Eligibility Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT03058679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.