NCT01951326

Who might be able to join this trial:

• You are willing and able to sign a consent form to take part in the study.
• You have been diagnosed with Crohn's Disease, confirmed by a scope, scan, or tissue sample, at least 6 months before joining the study.
• Your Crohn's Disease affects the small intestine (ileum) and/or the large intestine (colon).
• Your Crohn's Disease is considered moderately to severely active, based on a standard scoring system used by doctors (confirm with trial site for your specific score).
• You are currently taking at least one of the following medications at a stable dose: an anti-inflammatory called 5-ASA (stable for at least 4 weeks), a steroid (stable for at least 2 weeks), azathioprine, 6-mercaptopurine, or methotrexate (stable for at least 8 weeks), or infliximab or adalimumab (stable for at least 14 weeks).
• Your blood test shows a white blood cell count at or above a certain level, showing your immune system is working adequately (confirm with trial site).
• Blood tests, a stool sample, or a recent scan or scope confirms your Crohn's Disease is currently active.
• You agree to use reliable contraception throughout the study and for at least 6 weeks after your last dose of the study drug, unless you cannot become pregnant for medical or surgical reasons.

Who may not be able to join:

• Your Crohn's Disease only affects the mouth, upper digestive tract, or anus.
• You have previously had surgery to remove your entire large intestine or rectum.
• You currently have an active fistula (an abnormal tunnel caused by Crohn's), or had one heal within the last 2 months.
• You have a stoma, ostomy bag, or surgically created internal pouch.
• You have short bowel syndrome (a condition where a large part of the small intestine is missing or removed).
• You are scheduled to have bowel surgery.
• You have had a known blockage or a hole (perforation) in your bowel in the past 6 months.
• Your current Crohn's medication dose was recently changed or stopped within the required stable period before the study start (timeframes vary by medication — confirm with trial site).
• You have been treated with a medication called vedolizumab within the last 120 days, or most other biological therapies within the last 60 days.
• You have ever been treated with the antibiotics rifabutin or clofazimine.
• You have taken oral or injected antibiotics within the 4 weeks before joining the study (skin-applied antibiotics are allowed).
• You have taken probiotic supplements — not including yogurt or yogurt-based products — within the last 4 weeks.
• You are pregnant or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.