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Purpose Proton-pump inhibitors (PPIs) are frequently used to treat gastroesophageal reflux disease (GERD) in children, but recent evidence suggests a potential association between PPI treatment and some types of infections. The aim of this study was to assess the effectiveness of Lactobacillus rhamnosus GG (LGG) for the prevention of gastrointestinal and respiratory tract infections in children with GERD treated with PPI (omeprazol). Methods Children younger than 5 years with GERD were assigned by a computer-generated list to receive LGG (109 colony-forming units) or placebo, twice daily, concomitantly with PPI treatment for 4-6 weeks; they were followed up for 12 weeks after therapy. The primary outcome measures were the percentage of children with a minimum of one episode of respiratory tract infection and the percentage of children with a minimum of one episode of gastrointestinal infection during the study. Results Of 61 randomized children, 59 patients (LGG n=30; placebo n=29, mean age 11.3 months) were analyzed. There was no significant difference found between the LGG and placebo groups, either for the proportion of children with at least one respiratory tract infection (22/30 vs. 25/29, respectively; relative risk [RR] 0.85, 95% confidence interval [CI] 0.66-1.10) or for the proportion of children with at least one gastrointestinal infection (9/30 vs. 9/29, respectively; RR 0.97, 95% CI 0.45-2.09). Conclusion LGG was not effective in the prevention of infectious complications in children with GERD receiving PPI. Caution is needed in interpreting these results, as the study was terminated early due to slow subject recruitment.

ObjectiveTo systematically assess the diagnostic accuracy of the Clinical Dehydration Scale (CDS), the WHO Scale and the Gorelick Scale in identifying dehydration in children with acute gastroenteritis (AGE).DesignThree databases, two registers of clinical trials and the reference lists from identified articles were searched for diagnostic accuracy studies in children with AGE. The index tests were the CDS, WHO Scale and Gorelick Scale, and reference standard was the percentage loss of body weight. The main analysed outcomes were the sensitivity, specificity, positive likelihood ratio (LR) and negative LR.ResultsTen studies were included. In high-income countries, the CDS provided a moderate-to-large increase in the post-test probability of predicting moderate to severe (≥6%) dehydration (positive LR 3.9–11.79), but it was of limited value for ruling it out (negative LR 0.55–0.71). In low-income countries, the CDS showed limited value both for ruling in and ruling out moderate-to-severe dehydration. In both settings, the CDS showed poor diagnostic accuracy for ruling in or out no dehydration (ConclusionLimited evidence suggests that the CDS can help in ruling in moderate-to-severe dehydration (≥6%) in high-income settings only. The WHO and Gorelick Scales are not helpful for assessing dehydration in children with AGE.

The aim of this study was to evaluate the diagnostic accuracy of the Clinical Dehydration Scale (CDS), the World Health Organization (WHO) scale, and the Gorelick scale for dehydration assessment in children. A prospective, observational study was carried out between October 2014 and December 2016. Eligible participants were children aged 1 month to 5 years with acute diarrhea. After hospital admission, each patient's weight was recorded and the degree of dehydration based on three scales was assessed. The reference standard was the percentage weight change between the discharge and admission weights. The main outcomes were the sensitivity, specificity, positive likelihood ratio (LR), and negative LR. Of 128 children enrolled in the study, complete data were available from 118 patients for analysis. Most of children presented with no or mild dehydration. Only the CDS showed limited value in confirming a diagnosis of dehydration ≥6% (positive LR 3.9, 95% CI 1.1 to 9.1), with no value in ruling it out (negative LR 0.6, 95% CI 0.2 to 0.99).In our cohort, the CDS was of limited diagnostic value in ruling in severe dehydration in children with acute gastroenteritis. The WHO and Gorelick scales were not helpful in the assessment of dehydration. What is Known : • Treatment of acute gastroenteritis (AGE) is based on assessing and correcting the degree of dehydration. • Several scales combining various signs and symptoms have been developed, including the Clinical Dehydration Scale (CDS), and the World Health Organization (WHO) scale, and the Gorelick scale. None of these scales is internationally accepted for best accuracy in diagnosing dehydration in children. What is New: • The CDS was of limited diagnostic value in ruling in severe dehydration in children with AGE. • The WHO and Gorelick scales were not helpful in the assessment of dehydration.

Neurodevelopment has been linked, among other factors, to maternal and early infant diets. The objective of this review, which is part of the NUTRIMENTHE research project ‘The effect of diet on the mental performance of children’ (www.nutrimenthe.com), was to update current evidence on the effects of nutritional interventions such as iron, folic acid or n-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation during pregnancy and/or in early life on the mental performance and psychomotor development of children. In May 2014, we searched MEDLINE and The Cochrane Database of Systematic Reviews for relevant studies published since 2009. The limited updated evidence suggests that iron supplementation of infants may positively influence the psychomotor development of children, although it does not seem to alter their mental development or behaviour. The use of multivitamin-containing folic acid supplements during pregnancy did not benefit the mental performance of the offspring. Evidence from randomised controlled trials (RCT) did not show a clear and consistent benefit of n-3 LCPUFA supplementation during pregnancy and/or lactation on childhood cognitive and visual development. Caution is needed when interpreting current evidence, as many of the included trials had methodological limitations such as small sample sizes, high attrition rates, and no intention-to-treat analyses. Taken together, the evidence is still inconclusive. Large, high-quality RCT to assess the effects of supplementation with iron, LCPUFA or folic acid are still needed to further clarify the effects of these, and other nutrients, on neurodevelopment. Recent recommendations from scientific societies are briefly presented.

AIM We explored the diagnostic accuracy of the clinical dehydration scale (CDS), the World Health Organization (WHO) scale and the Gorelick scale for assessing dehydration in children admitted to a Tanzanian referral hospital. METHODS This was a prospective, observational study, carried out from April 2015 to January 2017 on children aged one month to five years admitted to the hospital with acute diarrhoea lasting less than five days. Before rehydration therapy, each patient's weight was recorded and the degree of dehydration was assessed based on the three scales. The reference standard was the percentage weight change between admission and discharge. The main outcomes were the sensitivity, specificity and positive and negative likelihood ratios (LRs) of the scales. RESULTS Data from 124 eligible patients were available. The CDS showed limited value for ruling in cases with some dehydration (LR 1.9, 95% confidence interval 1.1-2.8), but was of no value in assessing no and moderate to severe dehydration. The WHO and Gorelick scales were of no value in evaluating any degree of dehydration. CONCLUSION The WHO and Gorelick dehydration scales were no use for assessing dehydration in small children, and the CDS was of limited use for predicting cases with some dehydration.

Introduction: Inadequate vitamin D level is associated with altered bone turnover and bone loss, which increases the fracture risk. Aim: To assess the seasonal prevalence of inadequate (insufficient or deficient) serum vitamin D levels in community-dwelling postmenopausal Polish women screened for osteoporosis. Material and methods : A cross-sectional observational study based on the regional urban non-institutionalized sample (n = 107) of postmenopausal Caucasian women in the age range of 51-83 years, not taking any medication and free from any condition likely to affect vitamin D status or calcium/bone metabolism. The outcome measures were the mean 25-OH vitamin D level across all the seasons and the percentage of vitamin D deficiency and insufficiency and defined as < 20 ng/dl (50 nmol/l) and 20-30 ng/dl (50-75 nmol/l), respectively. Results: No statistically significant difference has been found in the mean vitamin D level, regardless of the season (p = 0.4). The prevalence of vitamin D deficiency and insufficiency were in spring 54% and 32%, in summer 46% and 46%, in autumn 67% and 27%, and in winter 61% and 22%, respectively. Conclusions : Vitamin D inadequacy is common in a sample of Polish community-dwelling postmenopausal women regardless of the season.

Aim. To systematically update diagnostic accuracy of the Clinical Dehydration Scale (CDS) in clinical recognition of dehydration in children with acute gastroenteritis. Methods. Six databases were searched for diagnostic accuracy studies in which population were children aged 1 to 36 months with acute gastroenteritis; index test was the CDS; and reference test was post-illness weight gain. Results. Three studies involving 360 children were included. Limited evidence showed that in high-income countries the CDS provides strong diagnostic accuracy for ruling in moderate and severe (>6%) dehydration (positive likelihood ratio 5.2-6.6), but has limited value for ruling it out (negative likelihood ratio 0.4-0.55). In low-income countries, the CDS has limited value either for ruling moderate or severe dehydration in or out. In both settings, the CDS had limited value for ruling in or out dehydration

To assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of functional constipation in children.A randomized, double-blind, placebo-controlled trial was conducted in 94 children aged5 years with functional constipation according to the Rome III criteria. Children were assigned to receive Lcr35 (8 × 10Eighty-one (86%) children completed the study. There was no significant difference in treatment success between the placebo and the Lcr35 group (28/40 vs 24/41, respectively; relative risk, 0.6, 95% CI 0.24-1.5, P = .4). There was a significant increase in the frequency of defecation from baseline to week 4 in both the placebo group (median [IQR] 2.0 [1.0, 2.0] to 6.0 [4.0, 9.0], P .001) and in the Lcr35 group (2.0 [1.0, 2.0] to 4.0 [3.0, 5.0], P .001), but the defecation frequency in the placebo group was significantly greater than that in the Lcr35 group at weeks 1, 2, 3, and 4.Lcr35 as a sole treatment was not more effective than placebo in the management of functional constipation in children5 years. This study adds to current recommendations that do not support the use of probiotics in the treatment of childhood constipation.ClinicalTrials.gov: NCT01985867.

Zaburzenia ze spektrum autyzmu (Autism Spectrum Disorders- ASD) są spowodowane zaburzeniami wczesnych faz rozwoju ośrodkowego układu nerwowego i zwykle są rozpoznawane w pierwszych latach życia. Pomimo wspólnych cech takich jak upośledzenie rozwoju społeczno-komunikacyjnego oraz stereotypowe zachowania posiadają zróżnicowany przebieg i obraz kliniczny. Do najważniejszych czynników etiologicznych należą geny i czynniki środowiskowe działające w okresie prenatalnym, perinatalnym i noworodkowym. Wskazuje się na rolę rzadko występujących wariantów genetycznych o dużej sile oddziaływania np. zmienności liczby powtórzeń w genach odpowiedzialnych za architekturę synaps i połączeń międzysynaptycznych. Postuluje się również udział występujących często wariantów o niewielkiej sile oddziaływania, w tym m.in. polimorfizmów w genach kodujących białka układu peptydów prospołecznych – oksytocyny i wazopresyny. Spośród środowiskowych czynników ryzyka wymienia się szkodliwe oddziaływania w czasie ciąży i porodu, choć do tej pory nie potwierdzono ich swoistego znaczenia, a niekiedy wskazuje się, że również niektóre z nich mogą wynikać pierwotnie z przyczyn genetycznych. W niektórych przypadkach, zwłaszcza z zaburzeniami towarzyszącymi– niepełnosprawnością intelektualną, padaczką i dysmorfiami- wskazuje się na celowość szczegółowej diagnostyki molekularnej, która obecnie może przyczynić się do wykrycia genetycznego podłoża zaburzenia w około 20% przypadków.

Summary Background A lack of reliable treatments for abdominal pain-related functional gastrointestinal disorders prompts interest in new therapies. Aim To evaluate systematically the effect of Lactobacillus rhamnosus GG (LGG) for treating abdominal pain-related functional gastrointestinal disorders in children. Methods MEDLINE, EMBASE, CINAHL, the Cochrane Library, trial registries and proceedings of major meetings were searched for randomised controlled trials (RCTs) evaluating LGG supplementation in children with abdominal pain-related functional gastrointestinal disorders based on the Rome II or Rome III criteria. Risk of bias was assessed for generation of the allocation sequence, allocation concealment, blinding and follow-up. Results Compared with placebo, LGG supplementation was associated with a significantly higher rate of treatment responders (defined as no pain or a decrease in pain intensity) in the overall population with abdominal pain-related functional gastrointestinal disorders (three RCTs, n = 290; risk ratio, RR 1.31, 95% CI 1.08–1.59, number needed to treat, NNT 7, 95% CI 4–22) and in the irritable bowel syndrome (IBS) subgroup (three RCTs, n = 167; RR 1.70, 95% CI 1.27–2.27, NNT 4, 95% CI 3–8). However, no difference was found in the rate of treatment responders between children with functional abdominal pain or functional dyspepsia who received placebo or LGG. The intensity of pain was significantly reduced in the overall study population and in the IBS subgroup. The frequency of pain was significantly reduced in the IBS subgroup only. Conclusion The use of Lactobacillus rhamnosus GG moderately increases treatment success in children with abdominal pain-related functional gastrointestinal disorders, particularly among children with IBS.

To systematically evaluate the effects of n-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation of pregnant and/or lactating women on the neurodevelopment and visual function of their children.Systematic review. Randomized controlled trials (RCTs) comparing n-3 LCPUFA maternal supplementation were identified through electronic databases (MEDLINE, EMBASE, the Cochrane Library) and the references of reviewed articles.Overall, 13 publications, some with important methodological limitations, were included. With regard to supplementation during pregnancy, among 3 RCTs that evaluated this intervention, 1 RCT (n = 72) showed significantly better eye and hand coordination assessed with the Griffiths Mental Development Scales at 30 months of age. Another RCT (n = 29) demonstrated an effect of n-3 LCPUFA supplementation on the cloth step of intentional solutions of the 2-step problem-solving test. No other effects were demonstrated. There was no consistent effect of n-3 LCPUFA supplementation during pregnancy on the children's visual acuity. With regard to supplementation during lactation, among 3 RCTs that assessed this intervention, 1 RCT (n =133) showed significant improvement on the Bayley Psychomotor Development Index in 30-month-old children; however, there was no influence of such supplementation on the results of different tests performed in the same group of children or in others. There was no consistent effect of n-3 LCPUFA supplementation during lactation on the children's visual function. Supplementation during pregnancy and lactation (3 RCTs) did not affect child neurodevelopment assessed up to 7 years of age.Evidence from RCTs does not demonstrate a clear and consistent benefit of n-3 LCPUFA supplementation during pregnancy and/or lactation on child neurodevelopment and visual acuity. These results should be interpreted with caution due to methodological limitations of the included studies.

SUMMARY Background Controversy exists surrounding the optimal treatment for inducing remission in active Crohn’s disease. Aim To review and update evidence on the effectiveness of enteral nutrition (EN) in treating active Crohn’s disease in children. Methods

Background and Aim: Adalimumab is well-established therapy for adults with Crohn’s disease [CD]. The aim of the study was to systematically assess the published evidence on the efficacy and safety of adalimumab for Crohn’s disease in children. Methods: MEDLINE, EMBASE, the Cochrane Library, and abstracts from the main gastroenterological meetings in the past 5 years were systematically searched up to July 2015 for randomised controlled trials and observational studies on the efficacy and safety of adalimumab for Crohn’s treatment in children and adolescents. Results: A total of 14 studies [1 randomised controlled trial, 13 case series], altogether including 664 patients [age: 1.9 to 21 years] were available for analysis. The studies differed with respect to patients’ characteristics, including percentage of infliximab-naive patients, disease duration, site of the disease, adalimumab doses, treatment duration, and follow-up period. The pooled remission rates were: 30% [ n = 93/309] at 4 weeks, 54% [ n = 79/145] at 3 months, 45% [ n = 18/40] at 4 months, 42% [ n = 146/345] at 6 months, 57% [ n = 20/35] at 8 months, and 44% [ n = 169/383] at 12 months. Of the total patients, 6% [ n = 13/207] were classified as primary non-responders and 12% [ n = 69/599] had severe adverse events reported including 2 deaths and 1 medulloblastoma. Withdrawal rate due to adverse events reported in one study was 35% [ n = 64/182]. Conclusion: According to low-quality evidence based mainly on case series, approximately half of children with Crohn’s disease on adalimumab therapy achieve remission during the first year of the therapy with reasonable safety profile. There is still a need for high-quality evidence on effectiveness and safety of adalimumab for paediatric Crohn’s disease.

Introduction Rectal faecal impaction (RFI) from functional constipation is a common problem in children. Maintenance therapy should start after successful disimpaction. However, there is uncertainty with regard to the optimal disimpaction regimen. Aim We systematically evaluated the effect of polyethylene glycol (PEG) compared to enema for treating RFI. Material and methods The MEDLINE, EMBASE, and the Cochrane Library, with no language restrictions, were searched up to July 2014 for randomised controlled trials (RCTs) evaluating the effect of PEG compared with enema for disimpaction in children with functional constipation. The risk of bias was assessed using the Cochrane risk of bias tool. Results Two RCTs, involving 170 children aged 1 to 17 years, met the inclusion criteria. The studies were generally low in methodological quality. Compared with the enema group, the PEG 3350 group had significantly reduced chance for treatment success, but the difference was of a borderline statistical significance (RR = 0.83, 95% CI: 0.7-0.99). The use of PEG was also more likely to increase defecation frequency, but increased the risk of watery stools and increased faecal incontinence. Other outcomes, in general, were similar in both groups. Conclusions Current evidence does not allow us to conclude which intervention is more effective for treating RFI in children with functional constipation. These results should be interpreted with caution due to the limited number of trials and the low quality of reporting in these trials, high or unknown risk of bias, and sparse data. Further high-quality, adequately powered RCTs are needed to determine the optimal management.

The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol (PEG) doses for the maintenance treatment of functional constipation in children.Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg (high-dose group; n = 45) or 0.3 g/kg (low-dose group; n = 47) for 6 weeks. Adjustment of the therapy was recommended in the event of3 bowel movements (BM) per week or ≥3 BM per day. The primary outcome measure was treatment success, defined as ≥3 BM per week with no fecal soiling during the last week of the intervention.A total of 90 of 92 randomized children, with a mean age of 3.7 ± 2.1 years, completed the study. In the analysis based on allocated treatment, treatment success was similar in both groups (relative risk 0.9, 95% confidence interval 0.78-1.03). Compared with the high-dose PEG group, the low-dose PEG group had an increased need for therapy adjustment of borderline significance (relative risk 2.0, 95% confidence interval 1.0-4.2), an increased risk of painful defecation, a lower number of stools per week, and lower parental satisfaction. Adverse events were similar in both groups.To achieve treatment success, both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation.

Treatment measures for constipation in children are often not satisfactory. The aim was to assess the efficacy of glucomannan (GNN) as a sole treatment for functional constipation.Children aged 3-16 years with functional constipation according to Rome III criteria were randomly assigned to receive GNN (2.52 g/d) or placebo for 4 weeks.Of the 80 children, 72 (90%) completed the study. The primary outcome, treatment success (≥3 stools per week with no soiling), was similar in the GNN (n = 36) and placebo (n = 36) groups (relative risk 0.95, 95% CI 0.6 to 1.4). In the GNN group, the stool consistency score was higher at week 1 (P 0.0001), lower at week 3 (P = 0.008), and similar at weeks 2 and 4. Stool frequency was higher only at week 3 (P = 0.007). Abdominal pain episodes were more frequent in the GNN group at week 1 (P = 0.04) and week 4 (P 0.0001) but were similar between groups at weeks 2 and 3. No difference was observed in the frequency of any other secondary outcome or adverse event.In our setting, GNN, as dosed in this study, was not more effective than placebo in achieving therapeutic success in constipated children. The trial was registered at ClinicalTrials.gov (http://clinicaltrials.gov), number NCT01151878.

Objective Search for evidence supporting target age, level of intervention and target values for low-density lipoprotein (LDL) cholesterol levels in children with familial hypercholesterolemia. Design Systematic review and meta-analysis. PubMed, Medline, CINAHL and Cochrane Reviews databases from 1966 to 2007 were searched for articles reporting statin therapy in children and adolescents aged 8–18 years. Retrieved articles were screened for double-blind randomised controlled trials (RCTs). Results Seven trials involving 884 patients met inclusion criteria. Meta-analysis findings showed significantly reduced total cholesterol, LDL cholesterol and apolipoprotein B, whereas high-density lipoprotein cholesterol and apolipoprotein A1 were significantly increased by statin therapy. Evidence on target level in children was limited to one study attainment of LDL cholesterol treatment target in 60% of the subjects in the treatment group and none in the placebo group reached their target LDL cholesterol. Evidence on the effect of statins on surrogate markers of atherosclerosis was limited to two studies (one RCT on the effect upon the carotid intima-media thickness (n=211; mean difference (MD) −0.01; 95% CI −0.03 to −0.00), and one showing that the mean absolute change in flow-mediated dilation after 28 weeks of statin treatment was significantly higher in the simvastatin group compared to placebo group (MD 2.7%; 95% CI 0.42 to 4.98). Conclusions There is no firm evidence regarding when to start statin treatment or what target LDL cholesterol level should be attained. Recent recommendations that favour statins as the first-line drug treatment for hypercholesterolemia are evidence based. Studying high-risk groups (obese or diabetic patients) and incorporating composite end points may help define treatment guidelines.