The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial

Abstract

Background: Probiotic functional foods are widely advertised to consumers primarily based on probiotic supplements. Objective: Determine if consumption of yogurt containing a high dose of probiotics improves health in children ages 1-3 years attending daycare/school centers. Subjects/Methods: Double-blinded, randomized, placebo-controlled, allocation concealment clinical trial. Setting: Outpatient participants in the Washington, DC area. Participants: 182 healthy children between the age of 1 and 3 years attending daycare/ school at least 3 days a week. Intervention: Active was a strawberry yogurt-based drink supplemented with Bifidobacterium animalis ssp. lactis (B. lactis) BB-12. The placebo was indistinguishable from the active drink, differing only in absence of the probiotic BB-12. Primary objective was to determine if consumption of a probiotic-containing yogurt-based drink decreases absences due to illnesses from daycare for children ages 1-3 years. Secondary was to determine if probiotic-containing yogurtbased drink improves overall parental satisfaction due to decreased absences from work and an overall healthier child. Results: There were no significant differences in the days of missed school per group, with 51.9% in the active group and 47.1% in the placebo group missing at least 1 day of school throughout the study. Additionally, there were no differences in any secondary outcomes among the groups. Conclusions: Consumption of a yogurt-based drink delivering 10 10 CFU of Bifidobacterium animalis ssp. lactis (B. lactis) BB-12 per day did not decrease the number of days missed of school due to an illness. Additional independent research on the potential of BB-12 to reduce illness in children needs to be conducted.

Bifidobacterium animalis subsp. lactis in prevention of common infections in healthy children attending day care centers – Randomized, double blind, placebo-controlled study

“…In contrast to gastrointestinal infections, all studies in children older than one year of age who attend day care centers found that probiotics significantly lowered the incidence of upper respiratory tract infections [5,6,9,15,16]. Moreover, in 2011 the Cochrane metaanalysis identified 10 trials which involved 3451 participants, not limited only to children [11].…”

Probiotics for the prevention of pediatric upper respiratory tract infections: a systematic review

“…as a single strain in seven RCTs [13,16,17,[20][21][22]24], strains of Bifidobacterium spp. in four RCTs [11,12,14,15] and different combinations of Lactobacillus and Bifidobacterium strains in three RCTs [18,19,23]. The duration of probiotic treatment varied between 3 and 12 months.…”

“…Of the total 14 RCTs, 13 involved healthy children or infants [11][12][13][14][15][16][18][19][20][21][22][23][24] and 1 involved hospitalized children [17]. Eight of the 14 included RCTs studied specific populations of children attending daycare.…”

“…From those, 14 individual RCTs were regarded as qualifying for inclusion in this review [11][12][13][14][15][16][17][18][19][20][21][22][23][24]. The detailed process of the selection of eligible trials is depicted graphically in Figure 1.…”

Probiotics and Respiratory Tract Diseases

“…However, the effects of one product cannot be transferred to another. In a study recently conducted by the same working group [28] and following a similar study design, the strain B . animalis ssp.…”