Patient Population

Included Patients:

Subjects must meet each of the following criteria for enrollment into the study:

  1. Aged 18 years or older
  2. Documented diagnosis of CD previously confirmed by endoscopy and histology at least 3 months prior to enrollment
  3. Taking any brand or dosage of an oral aminosalicylate for at least 6 months prior to enrollment
  4. Subject-confirmed compliance with current aminosalicylate therapy
  5. CD currently in clinical remission, defined as:
    1. An HBI score ≤ 4 at enrollment visit AND
    2. No escalation in medication for the treatment of a CD flare within 3 months prior to enrollment AND
    3. No use of systemic corticosteroids for CD (2 continuous weeks or more) within the 3 months prior to enrollment AND
    4. Clinician judgement of disease remission
  6. Able to participate fully in all aspects of the clinical trial
  7. Written informed consent obtained and documented

Excluded Patients:

Subjects who exhibit any of the following conditions are ineligible for the study:

  1. A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease associated colitis
  2. A diagnosis of short-bowel syndrome
  3. Active perianal disease (note: a history of perianal disease is permitted)
  4. Active fistulizing disease (note: a history of fistulizing disease is permitted)
  5. A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
  6. Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
  7. Any major resective bowel surgery for CD within 6 months prior to enrollment
  8. Unwillingness to stop taking aminosalicylates for the duration of the trial
  9. Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
  10. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject’s ability to participate fully in the study
  11. History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures