Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies

"Each lot of Lactobacillus and Bifidobacterium and placebo capsules to be used in this study will undergo bioburden testing (tested as per USP \<61\>) to ensure that each lot has:~* Not more than 2000 colony forming unit (CFU) of contaminating (other than the seven strains of bacteria used in the Lactobacillus and Bifidobacterium capsules) aerobic bacteria per gram or dose (whichever is greater);~* Not more than 200 CFU of yeasts and molds per gram or dose (whichever is greater); and~* No bile-tolerant Gram-negative bacteria, Escherichia coli, Salmonella species (in 10 gm), Pseudomonas aeruginosa, Staphylococcus aureus, and Clostridium species per gram or dose (whichever is greater; tested as per USP\<62\>)."

Placebo capsule manufactured in same facility as experimental capsule.