 
Volunteers Needed for Gut Check |
The purpose of this study is to develop a safe research method to test new vaccines designed to prevent Helicobacter pylori (H. pylori) infection of the stomach. This infection lives on the lining of the stomach and frequently is linked with stomach ulcer disease. If the infection is chronic, H. pylori can result in a form of stomach cancer.
There are many treatments available to cure H. pylori infection, but these treatments use two or more antibiotics to work. Nothing is available to prevent stomach ulcers from occurring in the first place.
"There is a clear need for a vaccine to prevent ulcers," said Sharon E. Frey, M.D., associate professor of internal medicine in the division of infectious diseases and immunology. "Hopefully, children can one day be vaccinated, since H. pylori infection is usually acquired in childhood, and early infection is more harmful."
Frey said this study is different from others because volunteers will be purposely infected with H. pylori, then treated and cured. This process of infection then will be used to challenge people who actually receive vaccine to see if the vaccine is effective.
"This ability to cause H. pylori infection and cure it is needed before vaccine studies can be done," Frey said. "This will allow volunteers who are vaccinated to be given H. pylori to prove the vaccine actually protects against the infection."
Similar methods have been used in the clinical development of vaccines and drugs against diarrhea and respiratory infections.
Four weeks after being infected, volunteers will receive antibiotic treatment to cure the H. pylori infection. Infection in most people would include mild symptoms such as nausea or stomach discomfort.
Up to 30 volunteers from different study sites in the United States are being recruited to participate. Six of those volunteers will come from the St. Louis area. The study will last about six months, and all volunteers will be compensated for their efforts.
If you are healthy, between 18 and 50, and have not had major abdominal surgery, chronic intestinal disease, immunosuppression, bleeding trouble, or alcohol or drug dependence, you may be eligible. To learn more about this study, call the Center for Vaccine Development at 577-8649.
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