[A multicentric study of a lactose free formula supplemented with Saccharomyces boulardii in children with acute diarrhea].
OBJECTIVE
In a double-blind, randomized, controlled, multicentric study, the study compared the efficacy of a specific adapted formula (lactose-free, high-mineral, low-osmolarity formula, containing rice and pectin fortified with Saccharomyces boulardii) in the management of infants with acute diarrhea with a standard formula used to feed healthy infants from birth.


METHODS
Seventy infants with an average age of 163 days+/-11.7 suffering from acute diarrhea with an average of 6.6+/-0.4 stools per day received, after randomization, either a standard (control) formula (n=36) or an adapted lactose-free formula fortified with S. boulardii (26mg/100ml; n=34). The duration of the diarrhea was defined as the time needed until the occurrence of the first normal stool after the last liquid stool.


RESULTS
At inclusion, the age, weight, and number of stools per day were the same in the two groups. There were 15 infants with rotavirus in the treated group and 13 in the control group. The duration of the diarrhea from time of inclusion was significantly reduced in the treated group (35.4+/-3.7h) versus the control group (67.1+/-5h; p<0.001), In both groups, with or without rotavirus, the duration of diarrhea did not depend on the presence or absence of rotavirus but only on the treatment. The average daily weight gain was significantly higher in the treated group compared with the control group (74.2+/-26.4g versus 23.7+/-6.7g; p<0.05). The oral rehydration solution consumption was, however, higher in the control group than in the treated group; the consumption of formula was higher in the treated group, but these differences were not significant. The number of stools as of Day 4 remained significantly higher in the control group than in the treated group. After 6.5 days, almost no S. boulardii was found in the stools.


CONCLUSIONS
In moderately dehydrated infants (<10 %), the use of a specially designed formula, containing S. boulardii (Novalac AD+/Diarinova+), significantly shortens the duration of diarrhea and allows quicker weight regain than a standard formula.
Département de pédiatrie, groupe hospitalier du Havre, 55 bis, rue Gustave-Flaubert, 76083 Le Havre cedex, France.
B
B
Le Luyer
G
G
Makhoul
J-F
JF
Duhamel
D000208:Acute Disease; D003968:Diarrhea, Infantile / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005440:Fluid Therapy; D006801:Humans; D007223:Infant; D041943:Infant Formula; D007787:Lactose Intolerance / Q000628:therapy*; D008297:Male; D019936:Probiotics / Q000008:administration & dosage*; D012400:Rotavirus Infections / Q000628:therapy; D012440:Saccharomyces; D015430:Weight Gain
Etude multicentrique, contrôlée en double insu d'une formule adaptée enrichie en Saccharomyces boulardii dans le traitement des diarrhées aiguës du nourrisson.