Clinical trial NCT02620007: Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease
Official title: Multicenter Double Blind Randomized Clinical Trial Assessing the Benefit of Adherent Invasive E. Coli Eradication in Adult Ileal and Ileo-colonic Crohn Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn Disease
Adherent-invasive E. Coli
Keywords: Adult
AIEC
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
timeFrame: week 12
Secondary outcomes:
measure: Mean variation of CDEISm
timeFrame: week 12
measure: Complete endoscopic remission
timeFrame: week 12
measure: No ulceration
timeFrame: week 12
measure: Clinical remission
timeFrame: 12 and 48 weeks
measure: Microbiota composition
timeFrame: weeks 12 and 48
measure: lpf positive AIEC bacteria in the stools
timeFrame: weeks 12 and 48
measure: Biological remission
timeFrame: weeks 4, 8, 12, 24, 36 and 48
measure: Side effects
timeFrame: week 12
Other outcomes:
Locations:
city: Le Kremlin Bicetre
country: France
facility: Gastroenterology department
city: Le Kremlin-Bicêtre
country: France
facility: Kremlin-Bicetre hospital
Study officials:
affiliation: Intestinal bacterial pathogenesis laboratory
name: Nicolas Barnich, MD PhD
role: STUDY_CHAIR
References: