Small, Open-Label Study Shows Potential Use of Novel Antibiotic Rifaximin for Crohn's Disease

Preliminary Findings Presented at Annual Gastroenterological Meeting

May 18, 2005


A small, open-label study conducted by physicians at NewYork-Presbyterian Hospital/Weill Cornell Medical Center suggests that there may be a new application for the novel antibiotic rifaximin in treating patients who suffer from severe Crohn's disease and who have not responded to other available medications for the disease.

The study was conducted by Dr. Ellen Scherl – Assistant Professor of Medicine at Weill Medical College of Cornell University, and Director of the Center for Inflammatory Bowel Disease in the Division of Gastroenterology and Hepatology, and at the Iris Cantor Women's Health Center at NewYork-Presbyterian/Weill Cornell – and Dr. Brian Bosworth, Fellow in the Division of Gastroenterology and Hepatology in the Department of Medicine at NewYork-Presbyterian/Weill Cornell.

The physicians are encouraged by the unexpected results of rifaximin, which was FDA-approved last year for traveler's diarrhea. They caution, however, that these preliminary findings still require larger, controlled studies. They note that what makes rifaximin a potentially ideal antibiotic treatment for Crohn's disease is that it remains primarily in the gut, has minimal side effects, and has a lower resistance than other antibiotics.

The researchers' analysis was performed on 8 patients. Both baseline and post-treatment disease activity were measured via the Harvey Bradshaw index, a simple clinical index of Crohn's disease severity.

Patients varied in age from 17 to 83 and had an initial Harvey Bradshaw index ranging from 6 to 16 (mean 10.9). Following the treatment with rifaximin (400 mg twice daily), the Harvey Bradshaw index of these patients decreased significantly, range 1 to 7 (mean 3.8), with a mean decrease in value of 7.1. There was a significant improvement in the Harvey Bradshaw index, and the median time to response was 8.9 days.

The cause of Crohn's disease is unknown; however, many scientists suspect that it is an abnormal response to bacteria in the gastrointestinal tract. It is this supposition that led researchers to analyze treatment with rifaximin, a non-absorbed oral antibiotic that is gut-selective with broad-spectrum in vivo activity against gram-positive and gram-negative enteric organisms.

Results of the analysis suggest that rifaximin may be a safe and effective treatment for Crohn's disease. Researchers say that this small assessment shows promise for those afflicted with Crohn's disease, and that the role of rifaximin in the induction and maintenance of remission of inflammatory bowel disease, as well as the optimal dosing schedule, should be explored in well-controlled, double-blinded clinical studies.

Crohn's disease is a chronic inflammatory disease of the intestines and is frequently referred to as inflammatory bowel disease (IBD). It primarily causes ulcerations (breaks in the lining) of the small and large intestines. IBD affects approximately 500,000 to 2 million people in the United States, affecting men and women equally. Common symptoms include abdominal pain, diarrhea, and weight loss. Less common symptoms include poor appetite, fever, night sweats, rectal pain, and rectal bleeding. The symptoms of Crohn's disease are dependent on the location, the extent, and the severity of the inflammation. There is currently no known cure.

Digestive Disease Week

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. DDW takes place May 14-19, 2005, in Chicago and is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT). The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine, and technology.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

The NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and its academic partner Weill Cornell Medical College. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory, and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education, and community service.