Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: a randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048].
BACKGROUND
Adjuvant therapy to ORT with probiotic bacteria for infants with acute watery diarrhea has been under active investigation. Most studies have been done in the developed world showing benefit only for viral mild gastroenteritis. We evaluated the effect of a milk formula containing one billion (109) cfu/ml of Lactobacillus casei strain GG (LGG) upon duration and severity of diarrhea in infants in an environment with more severe acute diarrhea, where etiologic agents other than rotavirus are involved more frequently, and where mixed infections are more prevalent.


METHODS
Male infants aged 3-36 months brought for treatment of acute watery diarrhea of less than 48 hours were eligible. After rehydration was completed with the WHO's oral rehydration solution, patients were randomly assigned to receive a milk formula either containing LGG or not. Stool volume was periodically measured using a devise suited to collect stools separate from urine. Duration of diarrhea was estimated based on stools physical characteristics.


RESULTS
Eighty nine patients received the placebo milk formula and ninety received the LGG containing formula. Both groups were comparable in their baseline characteristics. Total stool output was significantly larger (p = 0.047) in the LGG group (247.8 ml/kg) than in the placebo group (195.0 ml/kg). No significant differences were found in duration of diarrhea (58.5 hours with LGG vs. 50.4 hours with placebo), rate of treatment failure (21.1% with LGG vs. 18.0% with placebo), and proportion of patients with unresolved diarrhea after 120 hours (12.2% with LGG vs. 12.5% with placebo). The rate of stools with reducing substances after 24 hours of treatment increased significantly in both groups (from 41.4% to 72.2% with LGG and from 45.9% to 68.0% with placebo).


CONCLUSIONS
This study did not show a positive effect of LGG on the clinical course of acute watery diarrhea. Positive beneficial effects of LGG, as had been reported elsewhere, could have been masked in our study by worsening diarrhea due to transient lactose malabsorption. Further studies with low-lactose or non-lactose conveyors of LGG are desirable.
Salazar-Lindo
Eduardo
E
Department of Pediatrics, Cayetano Heredia Hospital, Lima, Peru. edsalaza@ec-red.com
Miranda-Langschwager
Percy
P
Campos-Sanchez
Miguel
M
Chea-Woo
Elsa
E
Sack
R Bradley
RB
D000208:Acute Disease; D002675:Child, Preschool; D003131:Combined Modality Therapy; D003968:Diarrhea, Infantile / Q000628:therapy*; D004231:Diuresis; D004311:Double-Blind Method; D005243:Feces; D005440:Fluid Therapy; D006801:Humans; D007223:Infant; D007225:Infant Food; D041943:Infant Formula; D007780:Lacticaseibacillus casei; D008297:Male; D019936:Probiotics / Q000627:therapeutic use*; D017211:Treatment Failure; D014839:Vomiting