Clinical Trial: Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle

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 Summary:

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


Sponsor: Hvidovre University Hospital

Current Primary Outcome: 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


Original Primary Outcome: Compare number of participants in remission [ Time Frame: 01-01-2014 ]

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


Current Secondary Outcome: 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


Original Secondary Outcome: Compare numbers of patients who enrolled the study in the 4 groups [ Time Frame: 01-12-2014 ]

Compare numbers of patients who enrolled 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


Information By: Hvidovre University Hospital

Dates:
Date Received: January 17, 2013
Date Started: May 2011
Date Completion:
Last Updated: August 9, 2013
Last Verified: August 2013