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

NCT ID: NCT02620007

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-06-30

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.

Conditions

Crohn Disease; Adherent-invasive E. Coli

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental arm

oral Ciprofloxacin 500 mg bid and oral Rifaximin 800 mg bid for 12 weeks

Group Type: EXPERIMENTAL

Ciprofloxacin

Intervention Type: DRUG

oral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks

Rifaximin

Intervention Type: DRUG

oral Rifaximin 800 mg bid for 12 weeks

Control arm

a placebo of Ciprofloxacin bid and a placebo of Rifaximin bid for 12 weeks

Group Type: PLACEBO_COMPARATOR

Ciprofloxacin Placebo

Intervention Type: DRUG

a placebo of Ciprofloxacin bid for 12 weeks

Rifaximin Placebo

Intervention Type: DRUG

a placebo of Rifaximin bid for 12 weeks

Interventions

Ciprofloxacin

oral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks

Intervention Type: DRUG

Rifaximin

oral Rifaximin 800 mg bid for 12 weeks

Intervention Type: DRUG

Ciprofloxacin Placebo

a placebo of Ciprofloxacin bid for 12 weeks

Intervention Type: DRUG

Rifaximin Placebo

a placebo of Rifaximin bid for 12 weeks

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Barnich, MD PhD

Role: STUDY_CHAIR

Intestinal bacterial pathogenesis laboratory

Locations

Kremlin-Bicetre hospital

Le Kremlin-Bicêtre, , France

Gastroenterology department

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

P140503

Identifier Type: -

Identifier Source: org_study_id