Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Ciprofloxacin
* Dietary Supplement: E. coli Nissle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciprofloxacin-EcN<br> | Drug: Ciprofloxacin<br>* Antibiotic<br>Dietary Supplement: E. coli Nissle<br>* Probiotic<br>|
| Experimental: ciprofloxacin-placebo<br> | Drug: Ciprofloxacin<br>* Antibiotic<br>|
| Experimental: placebo-EcN<br> | Dietary Supplement: E. coli Nissle<br>* Probiotic<br>|
| Placebo Comparator: placebo-placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare numbers of patients who completed the study in the 4 groups | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EcN, Nissle, Mutaflor, Ulcerative Colitis, antibiotics, Inflammatory Bowel Diseases