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To determine whether long-term consumption of a fermented infant formula could influence the incidence of acute diarrhea and its severity in healthy infants.Nine hundred seventy-one infants, ranging in age from 4 to 6 months, were included in a randomized, double-blind, placebo-controlled trial during a period of 5 months. They consumed daily either a fermented infant formula (FF) (fermentation with Bifidobacterium breve C50 and Streptococcus thermophilus 065) or a standard infant formula (SF) of the same nutritional composition.Number and duration of acute diarrhea episodes were evaluated. Severity of the episodes was determined by the number of hospital admissions, incidence of dehydration, number of medical consultations, number of oral rehydration solution prescriptions, and number of formula switches.Growth of the infants and acceptability of the formulas were identical in the two groups. Incidence, duration of diarrhea episodes, and number of hospital admissions did not differ significantly between groups. Episodes were less severe in the FF (fermented formula) group. There were fewer cases of dehydration 2.5%versus 6.1% (P = 0.01), fewer medical consultations (46%v 56.6%, P = 0.003), fewer ORS prescriptions 41.9%v 51.9% (P = 0.003) and fewer switches to other formulas (59.5%v 74.9%, P = 0.0001) in FF infants compared to SF.A fermented formula may reduce the severity of acute diarrhea among healthy young infants. This outcome may be linked to the bifidogenic effects of fermentation products and their interactions with the intestinal immune system.