To evaluate a multistrain, high-dose probiotic in the prevention of eczema.
A randomised, double-blind, placebo-controlled, parallel group trial.
Antenatal clinics, research clinic, children at home.
...Pregnant women and their infants.
Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 10(10) organisms/day) or matching placebo.
Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years.
The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91).
The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood.
ISRCTN26287422.
Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Although these organisms have a long record of safe ...use, it is important to identify any adverse effects in potentially vulnerable populations. In a randomized, double-blinded, placebo-controlled trial, we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants. Two strains of lactobacilli (Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08) and bifidobacteria (Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20) with a total of 1 x 10¹⁰ colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0-6 mo. Adverse events (AE) were classified according to WHO International Statistical Classification of Diseases criteria. Common symptoms were recorded by regular questionnaires. Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar. Compliance with the trial interventions, loss to follow-up, symptoms, drug usage, infant growth, method of feeding, visits to the doctor, and mothers' assessment of infant health were similar in the 2 groups. Fifteen (6.8%) mothers and 73 (33.2%) infants in the treatment group and 21 (9.0%) mothers and 75 (32.1%) infants in the placebo group reported AE (P = 0.49 and P = 0.84, respectively). Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group. None of the AE were attributed to the intervention. Our findings support the safe use of this consortium of organisms during pregnancy and early infancy.
Display omitted
•Impact of Lab4 probiotic/vitamin C on antibiotic prescribing in children was assessed in a randomised controlled study.•The incidence of oral antibiotic prescriptions was ...significantly reduced.•Children taking the multistrain probiotic based intervention had a lower risk of being prescribed oral antibiotics.•The number needed to treat to avoid one oral prescription is 6
As part of a randomised, double-blind, placebo-controlled study in children looking at the impact of a combination of a multistrain probiotic and vitamin C on upper respiratory tract infection symptoms, we have explored antibiotic prescription during the study. Antibiotic usage in children for acute respiratory tract infections is quite widespread. In this study the incidence rates for oral antibiotic prescriptions were significantly reduced in the Lab4 probiotic/vitamin C group compared to the placebo; children had a lower risk of being prescribed antibiotics (Risk Ratio: 0.60, 95 % CI: 0.39, 0.94, P = 0.0239, per protocol; Risk Ratio: 0.72, 95 % CI: 0.49, 1.05, P = 0.0890, intention to treat, respectively). These data suggest that supplementation with the probiotic/vitamin C may help to reduce antibiotic prescriptions in children.
In this pilot-scale, double-blind, placebo-controlled trial, 30 patients with
Helicobacter pylori infection were randomised into three groups prior to their 7 days eradication therapy, to study the ...effects of probiotic supplement comprising
Lactobacillus acidophilus and
Bifidobacterium bifidum on the intestinal microflora in response to antibiotic therapy. Group I received the placebo product from day 1 to day 15, Group II received placebo from day 1 to day 7 and probiotics from day 8 to day 15 and Group III received probiotics from day 1 to day 15. Patients provided stool samples for analysis on days 1, 7, 12, 17 and 27. For patients in Groups I and II, significant increases in the facultative anaerobe component of the microflora occurred between days 1 and 7. In Group I, the numbers remained elevated to day 27 but in Group II, the numbers decreased significantly between days 7 and 27 back to the starting levels. In Group III, the facultative anaerobe population remained stable throughout. The total anaerobe numbers increased significantly at day 27 than at day 1 for Group I, were unchanged throughout for Group II and decreased significantly for the patients in Group III between days 1 and 7 before reverting to the starting levels by day 27. From these results, it can be seen that probiotic supplementation modulates the response of the intestinal microflora to the effects of antibiotic therapy.
The effects of probiotic supplementation on the intestinal re-growth microbiota following antibiotic therapy were studied in a double-blind placebo-controlled study. In the placebo group, numbers of ...facultative anaerobes and enterobacteria increased significantly, and at day 35 the numbers were significantly higher in the placebo group than in the active group; in the active group, the numbers of bacteroides increased significantly. Although the numbers of enterococci in both groups did not change, in the placebo group the number of patients harbouring antibiotic-resistant enterococci post therapy increased significantly. There was no change in the incidence rate of antibiotic resistance among the patients in the probiotic group.
Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Although these organisms have a long record of safe ...use, it is important to identify any adverse effects in potentially vulnerable populations. In a randomized, double-blinded, placebo-controlled trial, we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants. Two strains of lactobacilli (Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08) and bifidobacteria (Bifidobacteriumanimalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20) with a total of 1 × 1010 colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0–6 mo. Adverse events (AE) were classified according to WHO International Statistical Classification of Diseases criteria. Common symptoms were recorded by regular questionnaires. Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar. Compliance with the trial interventions, loss to follow-up, symptoms, drug usage, infant growth, method of feeding, visits to the doctor, and mothers' assessment of infant health were similar in the 2 groups. Fifteen (6.8%) mothers and 73 (33.2%) infants in the treatment group and 21 (9.0%) mothers and 75 (32.1%) infants in the placebo group reported AE (P = 0.49 and P = 0.84, respectively). Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group. None of the AE were attributed to the intervention. Our findings support the safe use of this consortium of organisms during pregnancy and early infancy.
Background
Probiotic supplementation to mothers and/or their term‐born infants has been suggested to prevent allergic disease, in particular eczema; however, no studies have investigated probiotics ...for prevention of allergic diseases in very preterm infants. We evaluated the effect of a postnatal probiotic combination on development of allergic diseases in very preterm infants.
Methods
This sub‐study was an a priori secondary outcome of the ProPrems multi‐center, double‐blind, placebo‐controlled randomized trial (ANZCTR:12607000144415). ProPrems randomized 1099 very preterm infants to receive a probiotic combination or placebo from soon after birth until discharge from hospital or term corrected age (CA), whichever was earlier. Allergic disease (eczema, atopic eczema, food allergy, wheeze, atopic sensitization) was assessed in a subgroup of ProPrems infants (n = 281) as close to 12 months CA as possible by questionnaire, clinical examination, and skin prick tests to common allergens.
Results
There was no difference in eczema incidence between the probiotic and placebo groups (3530% of 118 infants vs 3727% of 137 infants, respectively, absolute difference 2.65%, 95% CI −8.45 to 13.75). Similarly, the incidence of atopic eczema (65% of 118 vs 32% of 137), food allergy (43% of 124 vs 21% of 154), wheeze (3931% of 127 vs 4529% of 154), and atopic sensitization (1413% of 106 vs 1311% of 123) were similar between the probiotic and placebo groups.
Conclusion
This study found no effect of postnatal administration of a probiotic combination on the incidence of allergic diseases or atopic sensitization in the first 2 years of life in children born very preterm. Evidence that probiotics are effective for prevention of allergic disease in premature infants remains lacking; adequately powered randomized controlled trials evaluating probiotic supplementation for allergy prevention in very preterm infants are needed.
We evaluated the effect of postnatal probiotic supplementation on the development of allergic diseases and atopic sensitization in very preterm infants. We found no difference in the incidence of allergic diseases or atopic sensitization between the probiotic and placebo groups. Although current guidelines recommend probiotics for prevention of allergic diseases in high‐risk infants, our findings demonstrate that there is insufficient evidence to determine whether the guideline recommendations are applicable to very preterm infants.
This position statement from the Heart Failure Association of the European Society of Cardiology Cardio‐Oncology Study Group in collaboration with the International Cardio‐Oncology Society presents ...practical, easy‐to‐use and evidence‐based risk stratification tools for oncologists, haemato‐oncologists and cardiologists to use in their clinical practice to risk stratify oncology patients prior to receiving cancer therapies known to cause heart failure or other serious cardiovascular toxicities. Baseline risk stratification proformas are presented for oncology patients prior to receiving the following cancer therapies: anthracycline chemotherapy, HER2‐targeted therapies such as trastuzumab, vascular endothelial growth factor inhibitors, second and third generation multi‐targeted kinase inhibitors for chronic myeloid leukaemia targeting BCR‐ABL, multiple myeloma therapies (proteasome inhibitors and immunomodulatory drugs), RAF and MEK inhibitors or androgen deprivation therapies. Applying these risk stratification proformas will allow clinicians to stratify cancer patients into low, medium, high and very high risk of cardiovascular complications prior to starting treatment, with the aim of improving personalised approaches to minimise the risk of cardiovascular toxicity from cancer therapies.
PDF
