Clinical trial NCT01772615: Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle
Official title: Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: EcN, Nissle, Mutaflor, Ulcerative Colitis, antibiotics, Inflammatory Bowel Diseases
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Compare number of participants in remission
timeFrame: 12 weeks
Secondary outcomes:
measure: Compare numbers of patients who completed the study in the 4 groups
timeFrame: 12 weeks
Other outcomes:
measure: E. coli strains
timeFrame: 12 weeks
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Copenhagen University
state: Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Andreas M Petersen, MD, ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Andreas M Petersen, MD, ph.d.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.