Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Phase 4

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Ciprofloxacin; Dietary Supplement: E. coli Nissle

• Registration Number: NCT01772615
• Lead Sponsor: Hvidovre University Hospital

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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-01-17
• Study First Posted: 2013-01-21
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ciprofloxacin-EcN	Ciprofloxacin	-
ciprofloxacin-EcN	E. coli Nissle	-
ciprofloxacin-placebo	Ciprofloxacin	-
placebo-EcN	E. coli Nissle	-

Primary Outcome Measures

Name	Time	Method
Compare number of participants in remission	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

Secondary Outcome Measures

Name	Time	Method
Compare numbers of patients who completed the study in the 4 groups	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

Trial Locations

Locations (1)

Hvidovre Hospital, Copenhagen University; 🇩🇰 Hvidovre, Copenhagen, Denmark