68; Table 4). There was no difference in antibiotics use in either arm among subjects who reported loperamide (Imodium) use (n = 49; Table 5). The number of days with diarrhea was similar in the two groups Neratinib cost when all patients were evaluated and also when the analysis was limited to those subjects who were fully adherent to the study protocol. The minimum and maximum grade for each type of toxicity was recorded for each patient, and frequency tables used to determine

toxicity patterns. Toxicities from AKSB or placebo were determined from the symptom diary kept by the subjects and were reviewed with the study nurse at the exit interview. The questions asked at the interview pertained to gastrointestinal or systemic side-effects that one may potentially expect from a probiotic. There was no statistically significant difference between the two arms for all AEs, except for constipation where subjects on AKSB were noted to have less constipation than placebo (Table 6). Self-reported AEs under the category “other” included free-text comments by participants regarding symptoms and grade. Of the listed symptoms,

one subject on AKSB reported a skin rash that was deemed as possibly related, however, not confirmed. One subject on placebo had an asymptomatic elevation find more of liver function tests after return from the trip. Follow-up liver function tests were normal. Hepatitis serologies were negative. The abnormal liver function values were deemed not related to the study drug. All returning subjects submitted a stool sample that was evaluated for pathogens by culture (Campylobacter species, Salmonella, Shigella, Aeromonas, and Yersinia), enterotoxigenic E coli toxin assay and ova and parasite. Only 10 of 196 (5%) specimens had a stool pathogen or parasite identified. Of these 10 stool specimens, a bacterial pathogen was identified in seven: Campylobacter (five), Aeromonas (one), and Salmonella (one). The rest had Endolimax nana (one) Exoribonuclease and

Blastocystis hominis (two). All these subjects were clinically asymptomatic at the time of post-travel stool collection. Of the seven subjects with a bacterial pathogen, three were in the AKSB arm. Leftover capsules were retrieved from 86 (43.8%) participants. Of these, 41 (47.6%) were AKSB synbiotic. Of the 41, 20 (48.8%) had at least five billion total CFU per capsule (range 1.05–8.70E+08) similar to the pre-study viable organisms. Although the total number of organisms decreased in 51.2% of the capsules, approximately half (52%) of those capsules still had more than 1.5 billion organisms per capsule. We conducted a randomized, placebo-controlled trial of a synbiotic to learn if TD could be prevented in healthy subjects traveling to a location where they would be at risk for TD.