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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Ciprofloxacin Dietary Supplement: E. coli Nissle||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
Dietary Supplement: E. coli Nissle
Dietary Supplement: E. coli Nissle
|Placebo Comparator: placebo-placebo|
- 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
- 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
- E. coli strains [ Time Frame: 12 weeks ]Compare changes in E. coli strains in the 4 groups
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
|Hvidovre Hospital, Copenhagen University|
|Hvidovre, Copenhagen, Denmark, 2650|
|Principal Investigator:||Andreas M Petersen, MD, ph.d.||Hvidovre University Hospital|
|Study Chair:||Andreas M Petersen, MD, ph.d.||Hvidovre University Hospital|