AIM: To analyse the effect of continuous consumption of Lactobacillus casei (DN-114001) fermented milk on the incidence of the infectious disorders frequent in children. FIELD: Infant and child population SUBJECTS:children from 3 to 12 years from two schools in Barcelona. A total of 251 children from both sexes participated in the study. INTERVENTIONS: A nutritional intervention study was carried out during 20 weeks with a parallel, prospective, double-blind and randomised by pragmatic clusters design. Participants were children from 3 to 12 years from two schools in Barcelona. One of the centres was assigned to receive two daily units of Actimel" and the other to two units of Placebo. From the 251 participants, 109 receivingplaceboand 142 receiving Actimel". Basal demographic characteristics and clinical history data were recorded, and the symptoms related to infectious disorders or other illnesses were monitored at weeks 12, 16 and 20. The analysis of the data was carried out on the intention-to-treat (ITT) population, being the principal endpoint the duration of respiratory and gastrointestinal symptoms. RESULTS: A one day difference, but non-significant, was seen in the median of total duration of days with illness through the study (Actimel group: 1 day vs Placebo group: 2 days). The same nonsignificant difference was also seen in the duration of days with respiratory (high and low respiratory tract infections) and with gastrointestinal (diarrhoea, vomiting, stomach pain and constipation) disorders. There was a statistical significantly difference found in favour of Actimel in the duration of the low respiratory tract infections, bronchitis or pneumonia, and in the duration of fatigue. There was also detected a lower incidence of children with low respiratory tract infections (32% vs. 49%) and with fatigue (3% vs. 13%) in the Actimel group compared to placebo. The satisfaction levels with the nutritional intervention were very high, over 80%. CONCLUSIONS: The study shows a tendency to the reduction of duration and incidence of some infectious disorders in those children receiving two daily Actimel during 20 weeks.
RCT Entities:
AIM: To analyse the effect of continuous consumption of Lactobacillus casei (DN-114001) fermented milk on the incidence of the infectious disorders frequent in children. FIELD: Infant and child population SUBJECTS:children from 3 to 12 years from two schools in Barcelona. A total of 251 children from both sexes participated in the study. INTERVENTIONS: A nutritional intervention study was carried out during 20 weeks with a parallel, prospective, double-blind and randomised by pragmatic clusters design. Participants were children from 3 to 12 years from two schools in Barcelona. One of the centres was assigned to receive two daily units of Actimel" and the other to two units of Placebo. From the 251 participants, 109 receiving placebo and 142 receiving Actimel". Basal demographic characteristics and clinical history data were recorded, and the symptoms related to infectious disorders or other illnesses were monitored at weeks 12, 16 and 20. The analysis of the data was carried out on the intention-to-treat (ITT) population, being the principal endpoint the duration of respiratory and gastrointestinal symptoms. RESULTS: A one day difference, but non-significant, was seen in the median of total duration of days with illness through the study (Actimel group: 1 day vs Placebo group: 2 days). The same nonsignificant difference was also seen in the duration of days with respiratory (high and low respiratory tract infections) and with gastrointestinal (diarrhoea, vomiting, stomach pain and constipation) disorders. There was a statistical significantly difference found in favour of Actimel in the duration of the low respiratory tract infections, bronchitis or pneumonia, and in the duration of fatigue. There was also detected a lower incidence of children with low respiratory tract infections (32% vs. 49%) and with fatigue (3% vs. 13%) in the Actimel group compared to placebo. The satisfaction levels with the nutritional intervention were very high, over 80%. CONCLUSIONS: The study shows a tendency to the reduction of duration and incidence of some infectious disorders in those children receiving two daily Actimel during 20 weeks.
Authors: Anna M Scott; Justin Clark; Blair Julien; Farhana Islam; Kristian Roos; Keith Grimwood; Paul Little; Chris B Del Mar Journal: Cochrane Database Syst Rev Date: 2019-06-18