Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257699
Status:
TERMINATED
Last Update Posted:
2008-08-12
First Post:
2005-11-22
Brief Title:
Study of Antibiotics in the Treatment of Colonic Crohns Disease
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Metronidazole and Ciprofloxacin in the Treatment of Colonic Crohns Disease The MACINTOCC Trial
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inadequate recruitment to meet completion date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns 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 factors 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 Crohns 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
CD is thought to arise from a combination of inherited genetic factors and some undefined environmental factors 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 Crohns 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
Detailed Description:
The role of bacteria and microbial agents in the pathogenesis of Crohns 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 Crohns 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 Crohns 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 Crohns disease the Antibiotics for Colonic Crohns Disease trial has been designed to determine if ciprofloxacin and metronidazole combination therapy is effective in the treatment of active Crohns 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 Crohns disease of the colon with or without ileal involvement as defined by a Crohns 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 ciprofloxacinmetronidazole and placebo groups Secondary outcome measures will evaluate partial response and adverse event rates
In order to better justify the use of antibiotics in the treatment of Crohns disease the Antibiotics for Colonic Crohns Disease trial has been designed to determine if ciprofloxacin and metronidazole combination therapy is effective in the treatment of active Crohns 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 Crohns disease of the colon with or without ileal involvement as defined by a Crohns 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 ciprofloxacinmetronidazole and placebo groups Secondary outcome measures will evaluate partial response and adverse event rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None