Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle
Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 13, 2013
August 1, 2013
2.3 years
January 17, 2013
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare number of participants in remission
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
12 weeks
Secondary Outcomes (1)
Compare numbers of patients who completed the study in the 4 groups
12 weeks
Other Outcomes (1)
E. coli strains
12 weeks
Study Arms (4)
ciprofloxacin-EcN
EXPERIMENTALciprofloxacin-placebo
EXPERIMENTALplacebo-EcN
EXPERIMENTALplacebo-placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age, \>/=18 years and diagnosed with ulcerative colitis
- CAI score of \>/=6 (active UC)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre Hospital, Copenhagen University
Hvidovre, Copenhagen, 2650, Denmark
Related Publications (2)
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.
PMID: 21676223BACKGROUNDPetersen 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.
PMID: 19695087BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas M Petersen, MD, ph.d.
Hvidovre University Hospital
- STUDY CHAIR
Andreas M Petersen, MD, ph.d.
Hvidovre University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, ph.d.
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
May 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
August 13, 2013
Record last verified: 2013-08