ABSTRACT
A randomised, double-blind, placebo-controlled trial was performed to investigate the health benefits of probiotic bacteria in infants when delivered in a follow-on infant formula. The study was conducted in Fuyang (Anhui Province, China) during winter and enrolled 192 healthy infants aged six to 12 months. Infants received one of three follow-on formulae daily for 12 weeks: supplemented with 106 cfu/g Bifidobacterium animalis subsp. lactis HN019 (n=64); 106 cfu/g Lacticaseibacillus rhamnosus HN001 (n=64); or without added probiotics (n=64). The primary endpoint was physician-confirmed bacterial or viral infections during the treatment period. Secondary endpoints included parentally reported (confirmed and unconfirmed) infections; antiviral or antibiotic treatments, and hospitalisation; stool frequency and consistency; infant growth; infant temperament; and adverse events. There were 8 cases of confirmed infection, all upper respiratory tract infections (URTIs). Confirmed URTIs were observed in 9.4% of the control group, compared to 3.1% in the HN001 group (P=0.273), and 0.0% in the HN019 group (P=0.028). A similar trend was observed for parentally reported URTIs, with 25.0% in the control group, compared with 14.1% in the HN001 group (P=0.119) and 9.4% in the HN019 group (P=0.019). No infants in the HN019 group were prescribed antibiotics or antivirals, compared with 3 (4.7%) in the HN001 group and 7 (10.9%) in the control group. No infants required hospitalisation. The probiotic-containing formulae were well-tolerated: there were no cases of diarrhoea or differences in stool frequency or characteristics, no differences in infant growth or temperament, and no treatment-related adverse events. This study directly compared the benefits of two different probiotics when added to follow-on infant formula at 106 cfu/g and consumed over a 12-week period. While HN001 showed trends toward reduced infections, HN019 showed better performance in terms of significantly reduced incidence of both physician-confirmed and parentally reported URTIs, and antibiotic/antiviral use compared to a control in Chinese infants. The trial is registered at ClinicalTrials.gov (NCT01724203).
Subject(s)
Bifidobacterium animalis , Probiotics , Respiratory Tract Infections , Anti-Bacterial Agents/therapeutic use , Antiviral Agents , Double-Blind Method , Humans , Respiratory Tract Infections/prevention & controlABSTRACT
BACKGROUND: Depressive and anxiety symptoms are common in children and youth and may impact outcomes for individuals with childhood-onset systemic lupus erythematosus. Research into the prevalence of depressive and anxiety symptoms and childhood-onset systemic lupus erythematosus comorbidity has reported conflicting results. OBJECTIVE: To synthesize current knowledge regarding the prevalence of depressive and anxiety symptoms in childhood-onset systemic lupus erythematosus. METHODS: Studies were identified through a comprehensive search of MEDLINE, EMBASE, PsychINFO, LILACS and Web of Science (from database inception to July 2018) using MESH headings and keywords for 'lupus erythematosus', and 'depression' or 'anxiety'. Included studies measured depressive and/or anxiety symptoms prospectively among children and youth aged 8 to 21 years with a diagnosis of childhood-onset systemic lupus erythematosus. Neuropsychiatric systemic lupus erythematosus was included. Studies without use of validated screening tools for major depressive disorder or anxiety disorders were excluded, as were studies where diagnosis was by retrospective analysis of patient charts. Data were extracted by two independent coders and where discrepancies occurred, agreement was reached by consensus. RESULTS: In total, 70 studies met the criteria for full text review and of these, 14 were included in the final analysis. The majority (70%) of studies were of cross-sectional design, with sample sizes ranging from 20 to 100 (mean = 48) participants. The mean age of participants was 15.9 years and participants were predominantly female. Prevalence rates for depressive symptoms ranged from 6.7% to 59%. Anxiety symptom prevalence was 34% to 37%. All studies employed self-report instruments to assess depressive and anxiety symptoms; none of the studies utilized a semi-structured diagnostic interview to make psychiatric diagnoses. Significant heterogeneity precluded meta-analysis of the data. CONCLUSIONS: Depressive and anxiety symptoms may be common comorbidities of childhood-onset systemic lupus erythematosus; however, current research is limited by a paucity of studies, small sample sizes and an inability to confirm psychiatric diagnoses. Future research addressing these limitations is needed.