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

Inclusion Criteria

1. Age ≥18

2. Documented diagnosis of Crohn's disease

3. sCDAI score >175

4. Documentation of receipt of a baseline stool sample by the data coordinating center
and hsCRP.

5. Access to a computer with internet and the ability to complete daily online surveys

6. Capable of providing consent to participate

7. Able to receive weekly food shipments delivered every Friday for 6 weeks

Exclusion Criteria

1. Pregnancy

2. sCDAI >400

3. Hospitalized patients

4. Anticipated need for surgery within 6 weeks of randomization

5. Use of the Specific Carbohydrate Diet within 4 weeks of screening

6. Start or change*** dose of thiopurines (azathioprine and 6-MP), methotrexate,
natalizumab, or vedolizumab within 12 weeks prior to screening

7. Start or change*** dose of anti-TNF agents (including infliximab (Remicade),
adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab
within 8 weeks prior to screening.

8. Start or change in dose of any 5-ASA medications within 2 weeks of screening.

9. Start or change dose of corticosteroids within 1 week of screening or a dose >20mg/day
prednisone or equivalent*

10. Use of antibiotics (other than topical formulations) for any reason within 2 weeks
prior to screening

11. Known symptomatic intestinal stricture.

12. Presence of an ostomy

13. Baseline stool frequency >4 bowel movements/day when well

14. BMI <16

15. BMI ≥40

16. Celiac disease

17. Documented C difficile colitis within four weeks of screening

18. Diabetes Mellitus requiring medication

19. Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical
care)

20. Known allergy to tree nuts or peanuts

21. Other conditions that would be a contraindication to any of the study diets or
preclude the participant from completing the study.

22. 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.

- 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.