Thank you for you information request on Florastor® (Saccharomyces boulardii) and prevention of Clostridium difficile. As you stated earlier, Ms. JS was recently transferred from another facility to Llano Estacado Estates for a higher level of care. JS is an 84 year old, female patient that has been diagnosed with Alzheimer’s dementia, anxiety, depression, insomnia, hypothyroidism, constipation, and gastro-esophageal reflux disease (GERD). She is currently on the following medications: Aricept® (donepezil) 10 mg PO daily, levothyroxine 50 mcg PO daily, Protonix® (pantoprazole) 40 mg PO daily, Cymbalta® (duloxetine) 60 mg PO daily, trazodone 50 mg PO HS prn, Tylenol® (acetaminophen) 650 mg PO prn pain, Miralax® (polyethylene glycol) 17 g PO
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boulardii would prevent antibiotic-associated diarrhea (AAD) or C. difficile-associated diarrhea (CDAD). A total of 275 patients, whose average age was 79.2 years old, were enrolled in the study which 134 receiving a placebo and 141 receiving S. boulardii and were monitored for diarrhea. Diarrhea, according to the study, meant having the passage of three or more liquid stools over days or at least five passages in a 48 hour period. Patients were monitored for the duration of the antibiotic treatment and for 12 weeks after discontinuation, with diarrhea during this timeframe being considered ADD and if it tested positive for C. difficile toxins, then it was considered CDAD. There were 71 patients who were unable to complete the study because of death during or after, transfer to another hospital, or discontinuation of the antibiotic treatment. This left 204 patients, whose average age was now 78.4 years old, who completed the study and were analyzed for occurrence of diarrhea. Of those 204, 98 received the placebo and 106 received S. boulardii capsules. There was no statistical difference in the occurrence of ADD (P=0.71) since 13 in the placebo group (13.3%) and 16 in the S. boulardii group (15.1%) developed diarrhea. The odds ratio (OR) was 1.16 with a 95% confidence interval (CI) of 0.53-2.56. A total of 5 patients tested positive for C. difficile toxin, 2 in the placebo group (2.0%) and 3 in the S. boulardii group (2.8%) (OR 1.4; 95% CI, 0.23-8.55; P=1.00). The study went on to assume that if even if the patients who were unable to complete the trial were included and developed ADD or CDAD that the results would not change citing P values over significance (P<0.05,
boulardii would prevent antibiotic-associated diarrhea (AAD) or C. difficile-associated diarrhea (CDAD). A total of 275 patients, whose average age was 79.2 years old, were enrolled in the study which 134 receiving a placebo and 141 receiving S. boulardii and were monitored for diarrhea. Diarrhea, according to the study, meant having the passage of three or more liquid stools over days or at least five passages in a 48 hour period. Patients were monitored for the duration of the antibiotic treatment and for 12 weeks after discontinuation, with diarrhea during this timeframe being considered ADD and if it tested positive for C. difficile toxins, then it was considered CDAD. There were 71 patients who were unable to complete the study because of death during or after, transfer to another hospital, or discontinuation of the antibiotic treatment. This left 204 patients, whose average age was now 78.4 years old, who completed the study and were analyzed for occurrence of diarrhea. Of those 204, 98 received the placebo and 106 received S. boulardii capsules. There was no statistical difference in the occurrence of ADD (P=0.71) since 13 in the placebo group (13.3%) and 16 in the S. boulardii group (15.1%) developed diarrhea. The odds ratio (OR) was 1.16 with a 95% confidence interval (CI) of 0.53-2.56. A total of 5 patients tested positive for C. difficile toxin, 2 in the placebo group (2.0%) and 3 in the S. boulardii group (2.8%) (OR 1.4; 95% CI, 0.23-8.55; P=1.00). The study went on to assume that if even if the patients who were unable to complete the trial were included and developed ADD or CDAD that the results would not change citing P values over significance (P<0.05,