Introduction. Intake of probiotics has been shown to be effective in the treatment of diarrhea. L. reuteri, a common bacteria in the gastrointestinal tract of humans, produces an antimicrobial substance called reuterin that may contribute to the prevention of colonization by enteropathogens. Aim. To establish the tolerance and dose response of a probiotic mixture containing Lactobacillus reuteri. Methods. A blinded, controlled community-based pilot clinical study was conducted with 72 children, ages 12 to 36 months. Children were randomized into four groups to receive either the control study feeding with no probiotic or a low (106 CFU), medium (108 CFU), or high dose (1010 CFU) of a probiotic blend containing L. reuteri, L. acidophilus and B. infantis added to a liquid nutritional beverage (PediaSure®). The study consisted of an entry evaluation, a three-week study feeding and a post-feeding evaluation. Intake of beverage and tolerance were monitored daily. Weekly evaluation of stool characteristics, and total Lactobacillus and L. reuteri fecal counts were done. Results. Intake, incidence of vomiting, abdominal discomfort, gas and stool characteristics were not statistically different among groups. None of the subjects had L. reuteri detected in feces at entry. Table Conclusions. Intake of a probiotic mixture containing L. reuteri at all doses was well tolerated. Lactobacillus colonization is transient, and level of fecal colonization of subjects is directly related to dose. Supported by Ross Products Division, Abbott Laboratories.

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