Biotherapeutic Agents

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Abstract
Objective. —To evaluate the potential of biotherapeutic agents (microorganisms with therapeutic properties) for the prevention and/or treatment of selected intestinal and vaginal infections. Data Sources. —The MEDLINE database was searched for all relevant articles published between 1966 and September 1995. Search terms used werebiotherapeutic agent, probiotic, Lactobacillus, Saccharomyces, Bifidobacterium, Candida, gastrointestinal-system, vaginitis, vaginosis-bacterial, and related terms. The bibliographies of obtained articles were also reviewed. Study Selection and Data Extraction. —All placebo-controlled human studies on biotherapeutic agents were reviewed. English-language open trials, case series and reports, and animal studies were reviewed only if they were especially relevant to providing information on the potential efficacy, adverse effects, or mechanisms of action of these agents. Data Synthesis. —Placebo-controlled studies have shown that biotherapeutic agents have been used successfully to prevent antibiotic-associated diarrhea (Lactobacillus casei GG, Bifidobacteriumlongum, B longumwithL acidophilus, andSaccharomyces boulardii), to prevent acute infantile diarrhea (Bifidobacterium bifidumwithStreptococcus thermophilus), to treat recurrentClostridium difficiledisease (S boulardii), and to treat various other diarrheal illnesses (Enterococcus faeciumSF68,L caseiGG, andS boulardii). There is also limited evidence forLactobacillus acidophilusin the prevention of candidal vaginitis. Few adverse effects have been reported. However, many of the studies tested only small numbers of patients or volunteers. Conclusions. —There is now evidence that administration of selected microorganisms is beneficial in the prevention and treatment of certain intestinal and, possibly, treatment of vaginal infections. In an effort to decrease the reliance on antimicrobials, the time has come to carefully explore the therapeutic applications of biotherapeutic agents. (JAMA. 1996;275:870-876)