Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Ciprofloxacin; Rifamycins; Rifaximin

Criteria

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 edentate, propylene glycol, red iron oxide E172),

• Previous extensive ileal surgery (≥ 1 meter as measured on the pathology and/or surgical report),

• Short bowel syndrome,

• Need for an intestinal resection for fistula, abscess or intestinal obstruction,

• Renal failure (creatinine clearance<30 mL/min/1.73m2),

• Liver failure (V factor<50%),

• Past history of epilepsy,

• No health insurance,

• Pregnant or lactating women,

• Refusal to have a double effective contraception,

• Patients already included in a biomedical research other than an observational study (e.g: registry, cohort).