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Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

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ClinicalTrials.gov Identifier: NCT01772615
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : August 13, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Purpose: The purpose of the study is to investigate if treatment with ciprofloxacin for one week followed by therapy with E. Coli Nissle (EcN) for seven weeks can influence disease activity among ulcerative colitis patients with disease flare-ups compared to placebo controls.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Ciprofloxacin Dietary Supplement: E. coli Nissle Phase 4

Detailed Description:

Ulcerative colitis (UC) is a chronic inflammatory bowel disease where existing treatments have proven to result in numerous side effects. An important causal factor for the development of the disease is an autoimmune cellular response against bacteria in the colon.

As a possible treatment, manipulation of the bacterial flora has been studied using the probiotic bacterium Escherichia coli Nissle 1917 (EcN). Studies on UC patients have shown that treatment with EcN is equally good at maintaining remission as the standard treatment with mesalazine. Furthermore, treatment with antibiotics such as ciprofloxacin have been studied for treatment of UC and some, but shortlived, effect has been described.

Patients are randomized to one of four treatment-arms: ciprofloxacin-EcN, ciprofloxacin-placebo, placebo-EcN or placebo-placebo.

Disease activity are quantitated with Colitis Activity Index (CAI) and quality of life by the Inflammatory Bowel Disease Questionnaire (IBDQ). Also, dietary interviews to examine the patients' dietary intake are completed and the patients' fecal-calprotectin-concentrations will be measured.

Hundred subjects with ulcerative colitis will be recruited for the study. Standard medical care and therapies will be continued throughout the study


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle
Study Start Date : May 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ciprofloxacin-EcN Drug: Ciprofloxacin
Antibiotic
Dietary Supplement: E. coli Nissle
Probiotic
Experimental: ciprofloxacin-placebo Drug: Ciprofloxacin
Antibiotic
Experimental: placebo-EcN Dietary Supplement: E. coli Nissle
Probiotic
Placebo Comparator: placebo-placebo


Outcome Measures

Primary Outcome Measures :
  1. Compare number of participants in remission [ Time Frame: 12 weeks ]
    Compare number of participants in remission (CAI </=4) in the four groups. Compare time to the patients achieve remission (CAI </=4) in the four groups


Secondary Outcome Measures :
  1. Compare numbers of patients who completed the study in the 4 groups [ Time Frame: 12 weeks ]
    Compare numbers of patients who completed the study in the 4 groups Compare IBDQ-score in the 4 groups Compare dietary intake in the 4 groups Compare the possible side effects of treatment in the different groups


Other Outcome Measures:
  1. E. coli strains [ Time Frame: 12 weeks ]
    Compare changes in E. coli strains in the 4 groups


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age, >/=18 years and diagnosed with ulcerative colitis
  • CAI score of >/=6 (active UC)

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Known sensitivity to ciprofloxacin
  • Subjects who participate in another clinical trial
  • Positive stool sample with any enteric pathogens, parasites or Clostridium difficile
  • Treatment with systemic corticosteroids or biologic therapy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772615


Locations
Denmark
Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Andreas M Petersen, MD, ph.d. Hvidovre University Hospital
Study Chair: Andreas M Petersen, MD, ph.d. Hvidovre University Hospital
More Information

Additional Information:
Publications:
Responsible Party: Andreas Munk Petersen, MD, ph.d., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01772615     History of Changes
Other Study ID Numbers: H-1-2009-10
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: August 13, 2013
Last Verified: August 2013

Keywords provided by Andreas Munk Petersen, Hvidovre University Hospital:
EcN, Nissle, Mutaflor, Ulcerative Colitis, antibiotics, Inflammatory Bowel Diseases

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors