Ulcerative Colitis
Conditions
Keywords
EcN, Nissle, Mutaflor, Ulcerative Colitis, antibiotics, Inflammatory Bowel Diseases
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
Interventions
DRUGCiprofloxacin
Antibiotic
DIETARY_SUPPLEMENTE. coli Nissle
Probiotic
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| E. coli strains | 12 weeks | Compare changes in E. coli strains in the 4 groups |
Countries
Denmark
Outcome results
None listed