Not provided
Not provided
Not provided
Not provided
insufficient recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks |
|
| Control arm | Placebo Comparator | a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | oral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean variation of CDEISm | assessed by centralized, anonymous and blinded reading of ileocolonoscopies | week 12 |
| Complete endoscopic remission | assessed by centralized, anonymous and blinded reading of ileocolonoscopies, and defined by a CDEISm <3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Barnich, MD PhD | Intestinal bacterial pathogenesis laboratory | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kremlin-Bicetre hospital | Le Kremlin-Bicêtre | 94043 | France | |||
| Gastroenterology department |
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rifaximin |
| Drug |
oral Rifaximin 800 mg bid for 12 weeks |
|
| Ciprofloxacin Placebo | Drug | a placebo of Ciprofloxacin bid for 12 weeks |
|
| Rifaximin Placebo | Drug | a placebo of Rifaximin bid for 12 weeks |
|
| week 12 |
| No ulceration | week 12 |
| Clinical remission | defined by Crohn's disease activity index (CDAI)<150 without steroids, anti-Tumor Necrosis Factor (TNF), and surgery | 12 and 48 weeks |
| Microbiota composition | weeks 12 and 48 |
| lpf positive AIEC bacteria in the stools | Detection (by PCR) | 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 | weeks 4, 8, 12, 24, 36 and 48 |
| Side effects | adverse events | week 12 |
| Le Kremlin-Bicêtre |
| 94 |
| France |
| D007410 | Intestinal Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |