The aim of this study was to evaluate the acceptability, safety & effect on diarrhea and accompanying symptoms of a probiotic mixture (Bacilac Forte) compared to placebo in children with a clinical diagnosis of mild acute gastroenteritis. The active product contained 3, 3 10 9CFU pro capsule of a probiotic mixture:20% Lactobacilus rhamnosus, 20% L acidophilus, 20% L casei, 20% L plantarum, 20% Bifidobacterium infantis. Study design was prospective DBPC in a primary care setting. IRB approval was obtained and subjects were included after parental consent. Otherwise healthy eutrophic children ages 1 mth-5 yrs, consulting their GP b/o liquid stools more than 3 tid for less than 48 h with dehydration less than 9% were included. Exclusion criteria were exposure to antibiotics or probiotics within 4 wks, bloody diarrhea & fever. Subjects received active or placebo tid. Parents kept a diary until D9 rating acceptability of the product, various parameters and any adverse event. Subjects were re-examined between D7-9. In total 48 subjects enrolled, 47 were analyzed (22 in the intervention group), 53% were girls, 91% Caucasian, age was 24+-15 mths, with no differences between groups. Average stool frequency was 5/d, 45% had cramps, 21% regurgitation, 45% vomiting and 23% upper respiratory symptoms. Statistical analysis used GLMM and non-parametric tests. Based on diary there was no difference in duration of diarrhea and stool frequency (although a sharper decrease in the active group) but stool consistency returned to normal more rapidly (D3) in the active group (p=0.0205). Also stools were more soft and formed over the observation period in the active group whereas subjects in the placebo group showed more variation (more hard and watery stools). During the course of the study there were no differences in cramps, regurgitation, vomiting, upper respiratory symptoms and appetite between groups. Acceptability of the capsules was rated easy by over 70% on all occasions for both groups, Tolererance was excellent: crying, flatulence, sleep and general behavior were rated similarly. Two adverse events (AE) were recorded in the intervention group: 1 otitis media and 1 gastroenteritis with dehydration necessitating hospitalization (frequency of AE not different for both groups by fisher exact p=0.203). In conclusion: tid administration of the probiotic mixture Bacilac Forte to young childrenwithmild gastro-enteritis was safe, well tolerated and led tomore rapid normalization of stool consistency with overall more formed and soft stools.