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

NCT02620007 | Terminated Phase 2 DMC

• 1 other identifier: P140503
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Keywords

Adult; AIEC

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Mean variation of CDEISm

  week 12

• Complete endoscopic remission

  week 12

• No ulceration

  week 12

• Clinical remission

  12 and 48 weeks

• Microbiota composition

  weeks 12 and 48

Study Arms (2)

Experimental arm

EXPERIMENTAL

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

Drug: Ciprofloxacin; Drug: Rifaximin

Control arm

PLACEBO COMPARATOR

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

Drug: Ciprofloxacin Placebo; Drug: Rifaximin Placebo

Interventions

Ciprofloxacin DRUG

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

Experimental arm

Rifaximin DRUG

oral Rifaximin 800 mg bid for 12 weeks

Experimental arm

Ciprofloxacin Placebo DRUG

a placebo of Ciprofloxacin bid for 12 weeks

Control arm

Rifaximin Placebo DRUG

a placebo of Rifaximin bid for 12 weeks

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 colonized with AIEC on initial ileal biopsies.

You may not qualify if:

• Ileal stenosis that cannot be crossed by the endoscope,
• 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).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Kremlin-Bicetre hospital

Le Kremlin-Bicêtre, 94043, France

Location

Gastroenterology department

Le Kremlin-Bicêtre, 94, France

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Ciprofloxacin; Rifaximin

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Nicolas Barnich, MD PhD

  Intestinal bacterial pathogenesis laboratory

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: June 1, 2022
• Last Updated: August 23, 2023

Record last verified: 2019-02

Locations

FR (2)