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

Assistance Publique - Hôpitaux de Paris

Status and phase: Terminated; Phase 2

Conditions: Adherent-invasive E. Coli; Crohn Disease

Treatments: Drug: Rifaximin; Drug: Ciprofloxacin; Drug: Rifaximin Placebo; Drug: Ciprofloxacin Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02620007

P140503

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Experimental arm

Experimental group

Description:

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

Treatment:

Drug: Rifaximin

Drug: Ciprofloxacin

Control arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Rifaximin Placebo

Drug: Ciprofloxacin Placebo