Study of Antibiotics in the Treatment of Colonic Crohn's Disease
Tracking Information | |||||
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First Received Date ICMJE | November 22, 2005 | ||||
Last Updated Date | August 11, 2008 | ||||
Start Date ICMJE | May 2006 | ||||
Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Complete response to therapy defined as a reduction of the CDAI score to below 150 points with a reduction of at least 70 points from baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Complete response to therapy at the end of eight weeks defined as a reduction of the CDAI score to below 150 points with a reduction of at least 70 points from baseline. | ||||
Change History | Complete list of historical versions of study NCT00257699 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Partial response (improvement) will be analyzed as a secondary outcome measure and will be defined as a reduction of the CDAI score by 70 points or more but with a final value of 150 points or greater. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Partial response (improvement) will be analyzed as a secondary outcome measure and will be defined as a reduction of the CDAI score by 70 points or more but with a final value of 150 points or greater. | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Antibiotics in the Treatment of Colonic Crohn's Disease | ||||
Official Title ICMJE | Metronidazole and Ciprofloxacin in the Treatment of Colonic Crohn's Disease: The MACINTOCC Trial. | ||||
Brief Summary | Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment. |
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Detailed Description | The role of bacteria and microbial agents in the pathogenesis of Crohn's disease has been suggested and is supported by animal models of inflammatory bowel disease (IBD) in which the presence of normal gut flora is required for the initiation and full expression of the inflammatory reaction. In human Crohn's disease, antibiotics are commonly used even though the evidence to support this practice is not strong. Several studies have indicated that antibiotics have some biological activity in Crohn's disease and that this activity may be most pronounced in the subset of patients with colonic involvement. In order to better justify the use of antibiotics in the treatment of Crohn's disease, the Antibiotics for Colonic Crohn's Disease trial has been designed to determine if ciprofloxacin and metronidazole combination therapy is effective in the treatment of active Crohn's disease of the colon. This two arm, multi-centre, randomized, double-blind, parallel-group, placebo-controlled study will involve 136 patients with mild to moderate active Crohn's disease of the colon (with or without ileal involvement), as defined by a Crohn's Disease Activity Index (CDAI) score between 220 and 450. Eligible patients will be randomly assigned to receive one of two treatment regimens: (1) ciprofloxacin (500 mg po bid; provided as 1 x 500 mg tablets) and metronidazole (<50 kg, 250 mg po bid; 50-75 kg, 250 mg po tid; >75 kg, 500 mg po bid; all doses provided as 1 x 250 mg tablets) or (2) placebo. Treatment will be continued for a period of 8 weeks. Treatment success will be defined as a complete response to therapy at the end of eight weeks. Complete response (remission) will be defined as a reduction of the CDAI score to below 150 points with a reduction of at least 70 points from baseline. Partial response (improvement) will be analyzed as a secondary outcome measure and will be defined as a reduction of the CDAI score by 70 points or more but with a final value of 150 points or greater. Patients who experience a persistent rise in their CDAI scores of 100 points or more on two consecutive visits or a rise in their CDAI score to 400 points or more at any visit will be considered to be treatment failures and will be withdrawn from the study. The primary analysis will be an intent-to-treat comparison of the proportion of patients achieving remission by 8 weeks in the ciprofloxacin/metronidazole and placebo groups. Secondary outcome measures will evaluate partial response and adverse event rates. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Crohn's Disease | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 12 | ||||
Completion Date | July 2008 | ||||
Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 16 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Canada | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00257699 | ||||
Other Study ID Numbers ICMJE | MSH REB 04-0257-A | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Mount Sinai Hospital, Canada | ||||
Collaborators ICMJE | Crohn's and Colitis Foundation | ||||
Investigators ICMJE |
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Information Provided By | Mount Sinai Hospital, Canada | ||||
Verification Date | August 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |