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As a compounded medication, this product is not evaluated by the United States Food and Drug Administration for safety or efficacy, and clinical use should therefore be guided by careful patient selection, informed consent, and ongoing monitoring to ensure that the lowest effective dose is employed for the shortest duration compatible with therapeutic goals

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1995;19:523-8. [PMID: 7590404]

Furthermore, elevations in the populations of pathogenic microbiota, including Escherichia coli , Shigella , Streptococcus , Proteobacteria , Fusobacteria , Enterococcus fecalis , Staphylococcus aureus and Veillonella have been documented in undernutrition, while beneficial bacteria Ruminococcaceae, and Actinobacteria were reduced [181, 194,195,196,197]