Clinical trial NCT00257699 (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: metronidazole placebo, ciprofloxacin placebo, ciprofloxacin, metronidazole
SMILES: [H][C@]1(NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](CCN)NC(=O)[C@H](CCNC1=O)NC(=O)[C@H](CCN)NC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)CCCCC(C)CC)[C@@H](C)O)[C@@H](C)O, OC(=O)C1=CN(C2CC2)C2=CC(N3CCNCC3)=C(F)C=C2C1=O, OC(=O)C1=CN(C2CC2)C2=CC(N3CCNCC3)=C(F)C=C2C1=O, [H][C@]1(NC(=O)[C@H](CCN)NC(=O)[C@H](CCN)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)[C@@H](CCN)NC(=O)[C@H](CCNC1=O)NC(=O)[C@H](CCN)NC(=O)[C@@H](NC(=O)[C@H](CCN)NC(=O)CCCCC(C)CC)[C@@H](C)O)[C@@H](C)O
Reason stopped: 
    inadequate recruitment to meet completion date
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 16 years of age or older.

          -  Patients who have been diagnosed with Crohn's disease for more than 1 month.

          -  Patients with CDAI scores between 220 and 450 at the randomization visit.

          -  Patients with Crohn's disease involving any portion of the colon (more than erythema
             and/or 10 aphthoid ulcers) with or without distal or terminal ileal disease. (Subjects
             may have had previous partial colonic resection consisting of less than 50% of the
             estimated length of the colon.)

        Exclusion Criteria:

          -  Female patients who are, or may become, pregnant during the course of the study or
             women who are breastfeeding.

          -  Patients who have an allergy or contraindication to ciprofloxacin or to metronidazole.

          -  Patients who are experiencing a complication of Crohn's disease (e.g. perforation,
             acute obstruction, hemorrhage) requiring urgent surgical intervention.

          -  Patients with subacute small bowel obstruction.

          -  Patients with significant, symptomatic Crohn's disease of the esophagus, the stomach,
             the duodenum, or the jejunum.

          -  Patients who have received, i)any antibiotic within 2 weeks of the screening visit,
             ii)systemic corticosteroid therapy within 2 weeks of the screening visit,
             iii)parenteral nutritional therapy within 2 weeks of the screening visit, iv)enteral
             elemental or polymeric nutritional therapy or exclusively liquid diet within 2 weeks
             of the screening visit, v) infliximab within 12 weeks of the screening visit, vi)an
             initiation of therapy with sulphasalazine or with any 5-ASA preparation within 4 weeks
             of the screening visit or a change in the dose within 2 weeks of the screening visit
             (Patients on stable doses of sulphasalazine or of a 5-ASA preparation for at least 2
             weeks prior to the screening visit are eligible for entry into the study if the total
             duration of the therapy is at least 4 weeks prior to screening.), vii)an initiation of
             azathioprine, 6-MP, or methotrexate within 12 weeks of the screening visit or changes
             in the dose of azathioprine, of 6-MP, or of methotrexate within 4 weeks of screening
             visit (Patients receiving azathioprine, 6-MP, or methotrexate for at least 12 weeks
             and at a stable dose for at least 4 weeks prior to the screening visit are eligible
             for inclusion.), viii)other therapy not listed above for Crohn's disease within 4
             weeks of the screening visit, AND/OR ix)any investigational drug within 12 weeks of
             the screening visit.

          -  Patients whose stool culture tests positive for enteric pathogens at the screening
             visit.

          -  Patients whose stool assay is positive for Clostridium difficile toxin at the
             screening visit.

          -  Patients who have another clinically significant medical or psychiatric illness (as
             judged by the investigator).

          -  Patients who have had a resection of more than 100 cm of their small intestine, more
             than half of their colon, or who have an ileostomy.

          -  Patients who are unable to provide informed consent.