ObjectiveTo summarize evidence on the efficacy and safety of the use of extensively hydrolyzed formulas (EHFs) for the treatment of children with cow's milk allergy (CMA).DesignSystematic review of randomized controlled trials (RCTs) per PRISMA guidelines. The risk of bias of included RCTs was assessed using the Cochrane Collaboration's risk of bias tool. In general, a narrative synthesis of the findings was performed. When sufficient data were available, a meta‐analysis using the random‐effect model was performed.Data sourcesThe Cochrane Library, MEDLINE, and EMBASE databases were searched up to February 2020.Eligibility criteriaRCTs, including cross‐over trials, assessing children of any age with any type of CMA that compared use of a formula containing extensively hydrolyzed bovine proteins (whey and/or casein) with use of any other formula for CMA management, were eligible for inclusion. Each type of EHF was evaluated separately. Outcome measures included allergic reactions (ie gastrointestinal, dermatological, and respiratory symptoms), growth, tolerance acquisition to cow's milk proteins, health‐related quality of life, and safety.ResultsFifteen trials reported in 18 publications (1285 children) fulfilled the inclusion criteria. The study findings were limited by numerous methodological issues, including differences in outcome measures and their definitions, lack of pre‐specified protocols and/or trial registration, and poor reporting of adverse events, methods of sequence generation and allocation concealment. The EHF products evaluated to date appear to be well‐tolerated by most children with CMA. However, published studies do not allow for any conclusion to be reached regarding the benefit of one formula over another formula intended for CMA management.ConclusionsThis systematic review highlights the need for standardized treatment protocols, including an agreed‐upon standardized set of outcomes that should be measured and reported in all clinical trials of specialized milk formula for the management of CMA.

Background The role of selenium (Se) in the management of type 2 diabetes mellitus (T2DM) remains unclear. We systematically assessed the effectiveness and safety of Se supplementation in adults with T2DM. Methods MEDLINE, EMBASE and the Cochrane Library were searched up to April 2018 for randomised controlled trials (RCTs) evaluating the effectiveness of Se against a comparator on DM‐related outcomes. Results Four RCTs (241 participants) were included. In individual RCTs, Se supplementation significantly reduced fasting insulin levels [mean difference (MD) = −3.6 μIU mL−1; 95% confidence interval (CI) = −6.36 to −0.84; MD = −5.8 μIU mL−1; 95% CI = −9.23 to −2.37], homeostasis model of assessment‐estimated insulin resistance (HOMA‐IR) (MD = −1; 95% CI = −1.79 to −0.21; MD = −1.6; 95% CI, −2.58 to −0.62) and homeostasis model of assessment‐estimated B cell function (HOMA‐B) (MD = −13.6; 95% CI = −23.4 to −3.8; MD = −22.6; 95% CI = −36.39 to −8.81). No effects of Se were noted on most of the other outcomes of interest. None of the RCTs assessed the mortality, diabetes‐related complications, non‐high‐density lipoprotein (non‐HDL), blood pressure and health‐related quality of life. The impact on HDL and fasting plasma glucose (FPG) was ambiguous. Only one adverse event (nausea) was reported as a reason for discontinuing the intervention; however, among the studies, the reporting was not accurate. Furthermore, only one RCT reported increase in FPG level in the Se group (MD = 36.38 mg dL−1; 95% CI = 15.39–57.37). Conclusions Currently, there is no evidence to support the effectiveness of Se supplementation in the T2DM population.

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Objectives:The available interventions for the management of children with functional abdominal pain disorders (FAPD) are limited. A diet low in fermentable oligosaccharides, disaccharides monosaccharides, and polyols (FODMAPs) is widely used in adults and children with FAPD, despite limited available evidence. We aim to systematically review evidence on the efficacy and safety of using a low-FODMAP diet for the management of children with FAPD. Methods: The Cochrane Library, EMBASE, and MEDLINE databases will be searched for randomized controlled trials (RCTs) that compare the use a low-FODMAP diet (preferably a 3-step low-FODMAP diet but also only a strict low-FODMAP diet or restriction of individual FODMAPs) with any comparator (i.e., standardized [i.e., average national] or other diet or no intervention) in children with FAPD (regardless of the definition). Each FAPD and each low-FODMAP diet or individual FODMAP restriction will be assessed separately. The Cochrane Collaboration's tool for assessing the risk of bias will be used. The primary outcome will be the abdominal pain intensity. The secondary outcomes will be abdominal pain frequency, stool consistency, other gastrointestinal symptoms, school performance, and psychological functioning associated with FAPD, parent's work absenteeism associated with FAPD of a child, health-related quality of life, compliance, growth, and adverse events. The findings will be published in a peer-reviewed journal and submitted to relevant conferences. Conclusion: This systematic review of rigorous methodological design will update current evidence on the efficacy and safety of using a low-FODMAP diet. However, it may be limited by the quality of the included studies.

Background Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders (FAPDs). However, in children, the evidence is very limited. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. Methods We will perform a randomized, quadruple-blinded, controlled trial. Seventy-four children aged 8 to 18 years with a FAPD (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks. The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS). Other outcomes will include changes in stool consistency, abdominal pain frequency, total scores on the Gastrointestinal Symptom Rating Scale, KIDSCREEN-10 Index and World Health Organization Five Well-Being Index, child’s school attendance and parents’ work absenteeism, and BMI-for-age z-score. Compliance, tolerability of the low-FODMAP diet, and adverse events also will be evaluated. Each FAPD subtype will be assessed separately. Discussion There is a need for high-quality evidence regarding the dietary management of children with FAPDs. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness, if any, of a low-FODMAP diet for the management of FAPDs in the pediatric population. The findings of this RCT will assist with the development of guidelines and influence the direction of further research. Trial registration NCT04528914 Data and protocol version identifier: 24/08/2020

ABSTRACT

The available nutritional interventions for the management of functional abdominal pain disorders (FAPD) in children are limited. 1,2 Evidence of the efficacy of implementing a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) is limited. 2 The rationale for use of a low-FODMAP diet is based on the assumption that a decrease in the short-chain fermentable carbohydrate load, both, prevents the osmotic effect of FODMAPs, resulting in a decrease in small intestine water volume, and limits the exaggerated fermentation of FODMAPs by colonic microbiota and associated gas production, which may alleviate recurrent abdominal pain (RAP). 3 A typical three-step low-FODMAP diet is commonly used in adults with IBS 4 (for a summary of the definitions of a low-FODMAP diet, see Table S1).However, in children with FAPD, a simplified version of the diet, called a "FODMAP-gentle diet" or "bottom-up approach" that excludes only a few foods with high concentrations of FODMAPs and/or a few targeted FODMAPs, also may be used to avoid over-restriction. 5,6 As for all restrictive diets, potential risks need to be considered.The main concerns associated with use of a low-FODMAP diet include alteration of the gut microbiota composition (i.e., decrease in the fecal Bifidobacterium spp.) and dietary inadequacy (including risk of lower

Summary Background The effects of early feeding practices on the risk of coeliac disease (CD) remain debated. Aims To update evidence on these practices on the risk of CD and/or CD‐related autoimmunity (CDA), defined as anti‐transglutaminase or anti‐endomysial antibody positivity Methods We searched MEDLINE, EMBASE and the Cochrane Library to May 2022 for randomised controlled trials (RCTs) and observational studies. Results We included 36 publications (30 studies). In the population at genetic risk of developing CD (HLA DQ2/DQ8‐positive), exclusive or any breastfeeding and longer breastfeeding duration did not reduce the risk of developing CD/CDA during childhood. While a meta‐analysis of four case–control studies showed a decreased risk for CD when gluten was introduced during breastfeeding, this was not shown in RCTs and cohort studies. Age at gluten introduction was not associated with cumulative CD/CDA risk, although two RCTs suggested that earlier gluten introduction was associated with earlier CDA appearance. Evidence from six observational studies suggests that consumption of a higher amount of gluten at weaning and/or thereafter may increase CD risk. There is insufficient evidence to determine the amount of gluten associated with an increased CD/CDA risk. Regarding whether infant feeding practices modulate the risk conferred by different HLA genotypes results were inconsistent. Conclusions For the population at genetic risk of CD, breastfeeding and age at gluten introduction have no effect on its cumulative incidence during childhood. There is some evidence for an effect of the amount of gluten consumed at weaning and/or thereafter on CD/CDA risk.