Lacticaseibacillus rhamnosus GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial

Abstract

Acute upper respiratory tract infections (URTIs) are caused by numerous viruses and bacteria. URTIs can be a cause of morbidity and are among the most common reasons for visiting healthcare practitioners and prescribing antibiotics to children in addition to causing absenteeism from school and work. Oral intake of Lacticaseibacillus rhamnosus GG DSM 33156 has shown beneficial health effects in several clinical trials, primarily relating to immune function and gastrointestinal health in children and adults. It has also been suggested that oral intake of L. rhamnosus GG DSM 33156 can reduce the incidence rate and alleviate symptoms of URTIs in children. We here report the results of a randomised, double-blind, placebo-controlled trial of 619 children aged 2-6 years conducted at a single centre in Scotland. The children, who were in day care or primary school, were followed over a 16-week intervention period with 309 randomised in the active group and 310 in the placebo group. The parents or guardians reported a daily healthcare status and any presumed episodes of URTI, which were subsequently confirmed by a general practitioner. The investigational product was well tolerated in the trial. Although a general trend towards a beneficial effect was observed, this trial did not demonstrate that L. rhamnosus GG DSM 33156 significantly reduced the incidence of URTIs, diagnosed by a general practitioner according to prespecified criteria (primary endpoint). Moreover, none of the secondary efficacy endpoints were met. Applying a Ward’s hierarchical clustering, two separate clusters, focussing on four quality of life-related endpoints, were identified. Cluster 1 was associated with more severe URTI characteristics than cluster 2. Cluster 2 was significantly enriched with children who consumed the product, indicating that the symptoms children experience during an URTI are alleviated by the intake of L. rhamnosus GG DSM 33156. The study is registered at ClinicalTrials.gov ID: NCT03636191.

Strain-Specificity of Probiotics in Pediatrics: A Rapid Review of the Clinical Evidence

“…There were 2 outcomes eligible for analysis. These were (i) duration of episodes ( L rhamnosus GG (27,30,31) and L rhamnosus HN001 (28)) and (ii) number of days of absence ( L rhamnosus GG (27,29,31) and L rhamnosus HN001 (28)). The tests for subgroup differences between the different strains of the same probiotic species showed no statistically significant differences between subgroups ( P = 0.27 for duration of episodes; P = 0.06 for number of days absent) but some heterogeneity ( I 2 = 18.5% and I 2 = 72.8%, respectively) (Figure 7, Supplemental Digital Content, http://links.lww.com/MPG/D27).…”

“…Five studies on respiratory tract infections were included (27)(28)(29)(30)(31). There were 2 outcomes eligible for analysis.…”

The impact of probiotics and vitamin C on the prevention of upper respiratory tract symptoms in two preschool children cohorts

“…Similar findings were reported in Malaysian children (aged 2 to 6 years) supplemented with Bifidobacterium longum BB536 at a dose of 5 × 10 9 cfu/day for 10 months [ 34 ]. Other studies have shown little or no effect [ 35 36 37 38 ]. Hay et al [ 39 ] reported the duration of URTI on average of 8 days in children in the community.…”