Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772615
• Other study ID #: H-1-2009-10
• Status: Completed
• Phase: Phase 4
• First received: January 17, 2013
• Last updated: August 9, 2013
• Start date: May 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Ciprofloxacin
Antibiotic

Dietary Supplement:
• E. coli Nissle
Probiotic

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital, Copenhagen University	Hvidovre	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Petersen AM, Nielsen EM, Litrup E, Brynskov J, Mirsepasi H, Krogfelt KA. A phylogenetic group of Escherichia coli associated with active left-sided inflammatory bowel disease. BMC Microbiol. 2009 Aug 20;9:171. doi: 10.1186/1471-2180-9-171. — View Citation

Vejborg RM, Hancock V, Petersen AM, Krogfelt KA, Klemm P. Comparative genomics of Escherichia coli isolated from patients with inflammatory bowel disease. BMC Genomics. 2011 Jun 15;12:316. doi: 10.1186/1471-2164-12-316. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	E. coli strains	Compare changes in E. coli strains in the 4 groups	12 weeks	No
Primary	Compare number of participants in remission	Compare number of participants in remission (CAI	12 weeks	No
Secondary	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	Yes

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