Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease (NCT02620007) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease
Stopped: insufficient recruitment
France24 participantsStarted 2015-12
Plain-language summary
The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* CD of the ileum, with or without involvement of the caecum or the right colon
* Colonoscopy showing active lesions defined by a CDEISm score \>6
* Informed consent to participate in this study
* Prescription of steroid treatments : Budesonide, Prednisone (or Prednisolone) independently from entry in study
* Patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in CDAI between the pre-inclusion and the inclusion visit,
* Patients colonized with AIEC on initial ileal biopsies.
Exclusion Criteria:
* Ileal stenosis that cannot be crossed by the endoscope,
* Infliximab treatment received less than 8 weeks before inclusion in this study,
* Adalimumab treatment received less than 4 weeks before inclusion in this study,
* Vedolizumab treatment received less than 8 weeks before inclusion in the study,
* Hypersensitivity to Ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide E171, macrogol 4000,),
* Tizanidine, Probenecid, Theophylline, Xanthine derivatives, Phenytoin, oral anticoagulants, and Ropinirole treatment,
* Hypersensitivity to Rifaximin, or to any excipients (sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide, disodium edenta…
What they're measuring
1
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3