Cystitis Research Center

- STAR Project -

Team of Virginia Medical Researchers to Conduct Scientific Study to Investigate Dr. Paul Fugazzotto's Bacterial Findings And Treatment Methods in Interstitial Cystitis Patients

For some time now there has been considerable debate about the methodology used by Dr. Paul Fugazzotto, microbiologist, in the testing and treatment of Interstitial Cystitis (IC) patients. Contrary to most other IC researchers who believe IC is of non-bacterial origin, Dr. Fugazzotto believes that Interstitial Cystitis is caused by gram-positive bacteria, usually enterococcus. He also believes that the agar cultures processed in labs today are not adequate in finding this pathogen.

Consistency in the identity of the same symptom-causing pathogen in so many IC patients, coupled with the fact that there have been many documented (and undocumented) success stories from the patients of Dr. Fugazzotto, demands that his findings be investigated further. So far, in spite of numerous pleas from IC patients, there have been NO scientific studies that duplicate his work. Bacterial studies performed in the past by researchers did not use the same length of time needed: in doing broth cultures, treating the patients, and in prescribing the correct antibiotics or the right dosages. Those who suffer from this devastating disease deserve that such findings, which could lead to a possible cure for IC, be investigated properly.

Dr. Helen Fillmore

We are very excited and pleased to announce that such a study, called the STAR (Solution To A Riddle) Project, is finally underway and being conducted by a professional medical research team in Virginia. The current research is being conducted under the direction of Dr. Helen Fillmore, Ph.D., molecular neuro biologist. She is an assistant professor at the Virginia Commonwealth University Medical Center (VCU) which has approved and is oveseeing the research. Her expertise is in the use of the Polymerase Chain Reaction (PCR) indetecting DNA in human tissue and fluids. She agreed to work with us to develop a test whereby the PCR could identify bacteria in urine specimens. This method requires the extraction of DNA or RNA fromthe urine and specific primers are designed to detect specific bacteria. An analogy for a primer would be a specific key that fits a specific lock. While other IC researchers have used the PCR, Helen's insight was that they did not use the best primers (chemicals) to find the bacteria we knew Dr. Fugazzotto was finding in most IC patients. She designed a test with specific primers with the help of plates from Dr. Fugazzotto showing the bacteria he was finding. She was able to identify the same bacteria as he was finding in donated patient samples.

Her expertise in the use of the PCR machine has moved the research ahead to a groundbreaking degree. We are now able to test/culture for bacteria with both the broth method, pioneered by Dr. Fugazzotto, and with the PCR. Developing a test on the PCR is extremely time-consuming and in June, 2003, we hired a full time biochemist, Dr. Denise Hines, to work on with us. we are currently finishing a study in which approximately 50 IC volunteers and 50 non-IC volunteers donated their urine for testing using both the traditional broth culturing method and the new PCR method. This was an approved study by our VCU Institutional Review Board committee. The samples are blinded and divided into two portions. One is sent to a well known clinical laboratory for the broth culture while one is tested here for the molecular (PCR) testing. To get to this point much time and effort was focused onthe design and testing of the PCR primers. We are currently comparing our PCR method with that of the broth culture method and will have the results in mid 2004. This could not have been done without the financial support of our IC friends.

Since we are testing the theories of Dr. Fugazzotto we plan to publish any results from this research on this site as soon as they are available.