Abstract
The growing popularity of biotherapeutic agents, probiotics and dietary supplements has lead to a variety of different types of health claims for these agents. Because these preparations are not as closely regulated as prescription or over-the-counter drugs, health claims are often stated without solid scientific proof of effectiveness or safety. The types of claims have included the prevention or treatment of various types of diarrhea (antibiotic-associated, C. difficile colitis, traveler's diarrhea, pediatric), prevention of cancer, lowering of cholesterol levels, food intolerance, stimulation of the immune system, dental health, vaginitis, urinary tract infections and the prevention of arthritis. This paper will review the type of evidence available for the most common types of health benefits associated with the use of living microbial agents. With the exception of the treatment or prevention of diarrhea, most of these health claims are not yet backed by multiple, large, placebo-controlled clinical trials that confirm significant efficacy and safety.