Clinical evaluation of the addition of lyophilized, heat-killed Lactobacillus acidophilus LB to oral rehydration therapy in the treatment of acute diarrhea in children.

BACKGROUND: Addition of a medication to the World Health Organization protocol for treatment of acute diarrhea in children is controversial. In this trial, the clinical efficacy of a medication (Lactéol Fort sachets; Laboratoire du Lactéol du Docteur Boucard, Houdan France) containing lyophilized heat-killed Lactobacillus acidophilus LB was assessed as an adjunct to oral rehydration therapy.

METHODS: Children aged 3 to 24 months with acute diarrhea and mild or moderate dehydration were enrolled in the study. Children received oral rehydration therapy for the first 4 hours. After this first rehydration phase, undiluted milk formula or breast milk was fed alternately with oral rehydration solution. Children were fed rice gruel as tolerated. They received either one sachet containing 10 billion of lyophilized heat-killed L. acidophilus LB or placebo at admission and at 12-hour intervals for five doses.

RESULTS: Seventy-three children (37 L. acidophilus LB, 36 placebo) were enrolled, of whom 40 (17 L. acidophilus LB, 23 placebo) received an antibiotic before inclusion. Rotavirus was identified in approximately 50% of the children in each group. After 24 hours of treatment, the number of rotavirus-positive children with watery stools was significantly lower (p = 0.012) in the L. acidophilus LB group. Mean duration of diarrhea was decreased (p = 0.034) with L. acidophilus LB (43.4 hours) versus placebo (57.0 hours). This decreased duration was particularly marked in children with no antibiotic therapy before inclusion (31.1 hours): 42.9 hours for the L. acidophilus LB group versus 74.0 hours for the placebo group (p = 0.016).

CONCLUSIONS: Addition of L. acidophilus LB to oral rehydration therapy was effective in the treatment of children with acute diarrhea by decreasing the duration of diarrhea.