Combination antibiotic therapy in treatment of active Crohn's disease
Research type
Research Study
Full title
A Pilot Randomised Study to Compare Antibiotic Therapy (Ciprofloxacin, Trimethoprim and Metronidazole) with Standard Therapy (Budesonide) in the Treatment of Active Crohn's Disease
IRAS ID
3586
Contact name
Jonathan M Rhodes
Sponsor organisation
Royal Liverpool & Broadgreen University Hospitals Trust
Eudract number
2008-001137-99
ISRCTN Number
21320/0007/001-0001
Research summary
There is increasing evidence that Crohn??s Disease is associated with reduced ability to clear bacteria that have invaded the intestinal lining. There is particular evidence showing increased numbers of E. coli bacteria multiplying within a type of white blood cell called the macrophage within Crohn's disease intestinal tissue. Laboratory studies have shown that two antibiotics: ciprofloxacin and trimethoprim, are particularly effective at killing E. coli that have been internalised within macrophages. There is also evidence that, once intestinal ulceration has occurred, a range of other bacteria invade the tissue, including many that might be susceptible to the antibiotic metronidazole. Previous studies have shown promising results in Crohn's disease treatment with ciprofloxacin and metronidazole but the combination of these antibiotics with trimethoprim has not been previously studied. Therefore, the main purpose of this study is to assess the efficacy and tolerability of 3 months treatment in active Crohn??s disease, comparing a combination of antibiotics (ciprofloxacin, trimethoprim, metronidazole), with standard therapy, the low-absorption steroid Budesonide (Entocort). Endpoints will separately assess efficacy at inducing remission/response and efficacy at reducing mucosa-associated bacteria, particularly E. coli.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
08/H1002/71
Date of REC Opinion
15 Dec 2008
REC opinion
Further Information Favourable Opinion