Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease
- Conditions
- Crohn DiseaseAdherent-invasive E. Coli
- Interventions
- Registration Number
- NCT02620007
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm Ciprofloxacin oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks Experimental arm Rifaximin oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks Control arm Ciprofloxacin Placebo a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks Control arm Rifaximin Placebo a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks
- Primary Outcome Measures
Name Time Method Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3 week 12 (assessed within each site quotation), defined by the modified Crohn's Disease Endoscopic Index of Severity (CDEISm)\< 6 and a decrease in CDEISm ≥ 3, as compared to baseline values.
- Secondary Outcome Measures
Name Time Method Microbiota composition weeks 12 and 48 Complete endoscopic remission week 12 assessed by centralized, anonymous and blinded reading of ileocolonoscopies, and defined by a CDEISm \<3
No ulceration week 12 Biological remission weeks 4, 8, 12, 24, 36 and 48 defined by haemoglobin level ≥13g/dL and C-Reactive Protein (CRP) serum level ≤5 mg/L and fecal calprotectin \<300 mg/L
Mean variation of CDEISm week 12 assessed by centralized, anonymous and blinded reading of ileocolonoscopies
Clinical remission 12 and 48 weeks defined by Crohn's disease activity index (CDAI)\<150 without steroids, anti-Tumor Necrosis Factor (TNF), and surgery
lpf positive AIEC bacteria in the stools weeks 12 and 48 Detection (by PCR)
Side effects week 12 adverse events
Trial Locations
- Locations (2)
Kremlin-Bicetre hospital
🇫🇷Le Kremlin-Bicêtre, France
Gastroenterology department
🇫🇷Le Kremlin Bicetre, France