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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
oral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks
oral Rifaximin 800 mg bid for 12 weeks
a placebo of Ciprofloxacin bid for 12 weeks
Kremlin-Bicetre hospital
Le Kremlin-Bicêtre, France
Gastroenterology department
Le Kremlin-Bicêtre, France
Percentage of patients with Endoscopic Endoscopic Index of Severity (CDEISm)< 6 and a decrease in CDEISm ≥ 3
(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.
Time frame: week 12
Mean variation of CDEISm
assessed by centralized, anonymous and blinded reading of ileocolonoscopies
Time frame: week 12
Complete endoscopic remission
assessed by centralized, anonymous and blinded reading of ileocolonoscopies, and defined by a CDEISm \<3
Time frame: week 12
No ulceration
Time frame: week 12
Clinical remission
defined by Crohn's disease activity index (CDAI)\<150 without steroids, anti-Tumor Necrosis Factor (TNF), and surgery
Time frame: 12 and 48 weeks
Microbiota composition
Time frame: weeks 12 and 48
lpf positive AIEC bacteria in the stools
Detection (by PCR)
Time frame: weeks 12 and 48
Biological remission
defined by haemoglobin level ≥13g/dL and C-Reactive Protein (CRP) serum level ≤5 mg/L and fecal calprotectin \<300 mg/L
Time frame: weeks 4, 8, 12, 24, 36 and 48
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a placebo of Rifaximin bid for 12 weeks
Side effects
adverse events
Time frame: week 12