Clinical trial NCT02793778 (phase 2, status: terminated)
Conditions: crohn's disease
ICD codes: K50.90, K50.913, K50.914, K50.911, K50.912, K50.918, K50.919
Drugs: crown, crown placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    enrollment
  
Eligibility criteria:

        Inclusion Criteria:

        Crohn's Disease patient who has derived clinical benefit from the Standard of Care therapy,
        but continues to have evidence of incomplete healing of the intestinal mucosa.

          1. Adults (18-85 years of age) with a known history of symptomatic CD confirmed by
             endoscopy or radiology

          2. CDAI score ≤ 350

          3. Active endoscopic disease (SES-CD score ≥ 6) documented during the study screening
             phase or SES-CD score ≥ 4 if isolated ileal disease

          4. On a stable dose of infliximab, adalimumab, or certolizumab therapy for 8 weeks prior
             to randomization as part of SOC

          5. Able to consume oral nutrition for up to 24 weeks consisting of two 4 oz (120 ml)
             servings daily

          6. Able to understand the informed consent process, willing to follow study instructions
             and likely to complete all required visits and procedures, including the use of an
             electronic device to collect study data, home computer or tablet and internet access
             to complete online food frequency questionnaire, and undergo 2 endoscopies in a 6
             month period

        Exclusion Criteria:

        Subjects with one or more of the following criteria are excluded from participation in the
        study:

          1. If female, subject is pregnant, nursing, or planning to become pregnant during the
             study period or is of childbearing potential and unable or unwilling to use a reliable
             form of contraception during the study

          2. Fistula known to be contributing to diarrhea

          3. Recent or current history of bowel obstruction

          4. Stricturing disease with evidence of bowel dilation proximal to stricture on imaging

          5. Anticipated need for gastrointestinal surgical therapy in the next 6 months

          6. Current treatment with a systemic corticosteroid at dose greater than 20 mg of
             prednisone (or equivalent) at screening

          7. Change in any antimetabolite therapy within 8 weeks prior to randomization

          8. Current treatment with antibiotics for CD (ciprofloxacin, metronidazole) at screening

          9. Current ostomy

         10. Serious infection, neoplasia or other medical conditions which would interfere with
             participation in the study, in the opinion of the Investigator

         11. Evidence of Clostridium difficile infection in the previous 4 weeks

         12. History of non-compliance with clinical protocols

         13. Active participation in another CD trial or received an investigational product within
             the past 4 weeks

         14. Diagnosis of celiac disease

         15. Known sensitivity to milk or soy protein

         16. In the Investigator's opinion, subject has any condition or situation which makes the
             subject unsuitable for study participation, may put the subject at significant risk,
             or may confound the study results