What Work Now Needs To Be Done
Large, randomized, double-blind, placebo-controlled trials are needed to prove efficacy of probiotics in the treatment of urogenital infections. However, getting FDA approval for such trials is currently problematic: While the FDA considers oral capsules containing probiotic organisms to be dietary supplements and not drugs, the same capsules would be considered drugs if vaginally inserted. In our studies, university ethics approval allowed vaginal insertion studies to take place, and indeed, some probiotic products are allowed for this use. Therefore, there is a precedent for vaginal probiotics as nondrug therapy in Canada, the United States, and elsewhere. However, regulations tend to be somewhat bureaucratic; given that probiotics are clearly not drugs, we believe that the FDA and other agencies should create a "middle ground" (not drug, not dietary supplement) for natural therapeutics that would allow their delivery other than by only oral ingestion. An FDA panel is reviewing this situation, but changes in legislation are a long way off.
Other studies that would be useful are an examination of healthy people who ingest probiotics vs those who do not. This would help to better understand long-term benefits of the therapy in terms of various outcomes, including cancer, cholesterol and heart disease, and mental well-being.
© 2001 Medscape
Cite this: Could Probiotics Be an Option for Treating and Preventing Urogenital Infections? - Medscape - Sep 21, 2001.