MedTrace Logo

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

NCT02620007 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-23

No results posted yet for this study

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

Interventions

DRUG

Ciprofloxacin

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

DRUG

Rifaximin

oral Rifaximin 800 mg bid for 12 weeks

DRUG

Ciprofloxacin Placebo

a placebo of Ciprofloxacin bid for 12 weeks

DRUG

Rifaximin Placebo

a placebo of Rifaximin bid for 12 weeks

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nicolas Barnich, MD PhD · Intestinal bacterial pathogenesis laboratory

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-08-31
Completion
2022-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620007 on ClinicalTrials.gov