Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle
NCT ID: NCT01772615
Last Updated: 2013-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2011-05-31
2013-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ciprofloxacin-EcN
Ciprofloxacin
Antibiotic
E. coli Nissle
Probiotic
ciprofloxacin-placebo
Ciprofloxacin
Antibiotic
placebo-EcN
E. coli Nissle
Probiotic
placebo-placebo
No interventions assigned to this group
Interventions
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Ciprofloxacin
Antibiotic
E. coli Nissle
Probiotic
Eligibility Criteria
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Inclusion Criteria
* CAI score of \>/=6 (active UC)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Andreas Munk Petersen
MD, ph.d.
Principal Investigators
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Andreas M Petersen, MD, ph.d.
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Andreas M Petersen, MD, ph.d.
Role: STUDY_CHAIR
Hvidovre University Hospital
Locations
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Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, Denmark
Countries
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References
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Vejborg RM, Hancock V, Petersen AM, Krogfelt KA, Klemm P. Comparative genomics of Escherichia coli isolated from patients with inflammatory bowel disease. BMC Genomics. 2011 Jun 15;12:316. doi: 10.1186/1471-2164-12-316.
Petersen AM, Nielsen EM, Litrup E, Brynskov J, Mirsepasi H, Krogfelt KA. A phylogenetic group of Escherichia coli associated with active left-sided inflammatory bowel disease. BMC Microbiol. 2009 Aug 20;9:171. doi: 10.1186/1471-2180-9-171.
Related Links
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Other Identifiers
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H-1-2009-10
Identifier Type: -
Identifier Source: org_study_id