Journal of pediatric gastroenterology and nutrition · 2007
Effectiveness and safety of Lactobacillus LB in the treatment of mild acute diarrhea in children.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Salazar-Lindo Eduardo, Figueroa-Quintanilla Dante, Caciano Maria Isabel, Reto-Valiente Victoria, Chauviere Gilles, Colin Patrick, Lacteol Study Group
Аннотация
BACKGROUND: Acute diarrhea is an important cause of morbidity and mortality in children. Oral rehydration salts (ORS) have lowered mortality without having an effect on the duration or severity of diarrhea. Some studies have reported that heat-killed Lactobacillus bacteria have a beneficial effect in the treatment of acute diarrhea. In this placebo-controlled study the duration of diarrhea was compared for 2 types of treatment: Lactobacillus LB (Lacteol) in association with oral rehydration and oral rehydration alone.
PATIENTS AND METHODS: A total of 80 nondehydrated children between the ages of 3 months and 4 years with acute watery diarrhea were randomly assigned to be treated with Lactobacillus LB or placebo plus ORS. The primary endpoint was the duration of diarrhea; intake of ORS and change in body weight between the time of randomization and the last assessment were also measured.
RESULTS: In 71 of the 80 patients, diarrhea was resolved: 36 in the Lactobacillus LB group and 35 in the placebo group. Several clinical characteristics of the 2 treatment groups were comparable at baseline. Median duration of diarrhea was 16.6 hours in the placebo group compared with 10.0 hours in the Lactobacillus LB group (P = 0.275). In the subgroup with a duration of diarrhea of more than 24 hours at inclusion, duration of diarrhea measured from that point was shorter for the Lactobacillus LB group (30.4 h vs 8.2 h; P = 0.044). ORS intake was similar for both groups. Lactobacillus LB was well tolerated, with only one patient experiencing an adverse effect.
CONCLUSIONS: Lactobacillus LB is an effective and safe treatment for children with well-established diarrhea (>24 h).
PATIENTS AND METHODS: A total of 80 nondehydrated children between the ages of 3 months and 4 years with acute watery diarrhea were randomly assigned to be treated with Lactobacillus LB or placebo plus ORS. The primary endpoint was the duration of diarrhea; intake of ORS and change in body weight between the time of randomization and the last assessment were also measured.
RESULTS: In 71 of the 80 patients, diarrhea was resolved: 36 in the Lactobacillus LB group and 35 in the placebo group. Several clinical characteristics of the 2 treatment groups were comparable at baseline. Median duration of diarrhea was 16.6 hours in the placebo group compared with 10.0 hours in the Lactobacillus LB group (P = 0.275). In the subgroup with a duration of diarrhea of more than 24 hours at inclusion, duration of diarrhea measured from that point was shorter for the Lactobacillus LB group (30.4 h vs 8.2 h; P = 0.044). ORS intake was similar for both groups. Lactobacillus LB was well tolerated, with only one patient experiencing an adverse effect.
CONCLUSIONS: Lactobacillus LB is an effective and safe treatment for children with well-established diarrhea (>24 h).