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Environmental enteric dysfunction (EED) predisposes children throughout the developing world to high rates of systemic exposure to enteric pathogens and stunting. Effective interventions that treat or prevent EED may help children achieve their full physical and cognitive potential. The objective of this study is to test whether 2 components of breast milk would improve a biomarker of EED and linear growth during the second year of life. A prospective, randomized, double-blind, placebo-controlled clinical trial among children aged 12-23 months was conducted in rural Malawi. The experimental group received a daily supplement of 1.5 g of lactoferrin and 0.2 g of lysozyme for 16 weeks. The primary outcome was an improvement in EED, as measured by the change in the percentage of ingested lactulose excreted into the urine (Δ%L). Among 214 children who completed the study, there was a significant difference in Δ%L between the control and experimental groups over 8 weeks (an increase of 0.23% vs 0.14%, respectively; P = 0.04). However, this relative improvement was not as strongly sustained over the full 16 weeks of the study (an increase of 0.16% vs 0.11%, respectively; P = 0.17). No difference in linear growth over this short period was observed. The experimental intervention group had significantly lower rates of hospitalization and the development of acute malnutrition during the course of the study (2.5% vs 10.3%, relative risk 0.25; P < 0.02). Supplementation with lactoferrin and lysozyme in a population of agrarian children during the second year of life has a beneficial effect on gut health. This intervention also protected against hospitalization and the development of acute malnutrition, a finding with a significant clinical and public health importance. This finding should be pursued in larger studies with longer follow-up and optimized dosing.

Background Chronic childhood malnutrition, as manifested by stunted linear growth, remains a persistent barrier to optimal child growth and societal development. Environmental enteric dysfunction (EED) is a significant underlying factor in the causal pathway to stunting, delayed cognitive development, and ultimately morbidity and mortality. Effective therapies against EED and stunting are lacking and further clinical trials are warranted to effectively identify and operationalize interventions. Methods/design A prospective randomized placebo-controlled parallel-group randomized controlled trial will be conducted to determine if a daily supplement of lactoferrin and lysozyme, two important proteins found in breast milk, can decrease the burden of EED and stunting in rural Malawian children aged 12–23 months old. The intervention and control groups will have a sample size of 86 subjects each. All field and laboratory researchers will be blinded to the assigned intervention group, as will the subjects and their caregivers. The percentage of ingested lactulose excreted in the urine (Δ%L) after 4 h will be used as the biomarker for EED and linear growth as the measure of chronic malnutrition (stunting). The primary outcomes of interest will be change in Δ%L from baseline to 8 weeks and to 16 weeks. Intention-to-treat analyses will be used. Discussion A rigorous clinical trial design will be used to assess the biologically plausible use of lactoferrin and lysozyme as dietary supplements for children at high risk for EED. If proven effective, these safe proteins may serve to markedly reduce the burden of childhood malnutrition and improve survival. Trial Registration Clinicaltrials.gov, NCT02925026 . Registered on 4 October 2016.

Background/Objectives: Physical activity and exploration in infancy affect physical and cognitive development. Nutritional supplementation improves activity in severely malnourished infants, but the evidence in mild-to-moderately malnourished and nutritionally at-risk infants is equivocal. We tested the effect of multiple-micronutrient supplementation on physical activity and exploration in Mexican infants. Subjects/Methods: Using a quasi experimental design, we analyzed data from a supplementation study that lacked a placebo-control group. We compared infants between 8 and 12 months measured at baseline who had received no supplementation (comparison group, n=78), with infants 8–12 months measured after 4 months of daily supplementation (treatment group, n=109). The treatment consisted of three supplement types: micronutrient powder, syrup (each containing only micronutrients) and a milk-based, fortified-food supplement (FFS; containing micronutrients and macronutrients). We formed the micronutrient-only group (MM) by combining the micronutrient powder and syrup groups. We measured activity and exploration by direct observation and used cluster analysis to form and characterize activity and exploration clusters. We performed logistic regression with activity or exploration cluster as the outcome variable and treatment versus comparison and MM or FFS versus comparison as the predictor variables. Results: Treatment versus comparison increased the odds of being in the high activity (odds ratio (OR)=2.35, P<0.05) and high exploration (OR=1.87, P<0.05) cluster. MM increased the odds of being in the high activity (OR=2.64, P<0.05) cluster and FFS increased the odds (OR=3.16, P<0.05) of being in the high exploration cluster. Conclusions: Nutritional supplementation benefited activity and exploration in this sample of Mexican infants.

Objective: To determine the differential efficacy and safety of twice-weekly administration of 3 RDAs of iron and folic acid, with and without a complement of 2 RDAs of 11, and 1 RDA of 3 additional essential micronutrients as compared to a placebo control (PlbCON) given as foodLETs. Subjects/Methods: A total of 250 children aged 6-24 months were enrolled after recruitment by village health workers; 19 of them dropped out during the trial. Children were assigned to one of three treatment arms and followed for 20.5 weeks; 41 supervised twice-weekly dosings of 30 mg of iron plus folic acid, either with or without accompanying micronutrients or placebo were given as foodLETs, a tool for ready-to-eat fortification in infant food. Initial and final measurements of anthropometry and blood biomarkers for hematological, iron stores and inflammatory status, as well as for abnormal hemoglobin (Hb), were obtained. Symptoms of listlessness, vomiting, watery stools and acute respiratory infections were monitored weekly. Results: Iron-containing supplements increased Hb concentrations significantly (P<0.0001) and virtually eradicated any IDA, as compared to no change in hematological status in the PlbCON group (P=0.011). Iron stores, as reflected by ferritin, increased significantly with iron-containing treatments (P<0.0001). Responses were as effective in individuals with HbE as in those with exclusively HbA phenotypes. Watery stools (P=0.002) and listlessness (P=0.001) were significantly more frequent in those receiving iron and folic acid alone than in the PlbCON group. In contrast, acute respiratory infections (P=0.014) and listlessness (P=0.001) were significantly less frequent in those receiving the multiple micronutrient formulation than in the PlbCON group. Conclusions: Supplementation of micronutrients along with iron and folic acid mitigates the excess morbidity of iron-folate alone, without reducing its efficacy in correcting anemia and building iron stores. FoodLETs are a suitable vehicle to provide micronutrient supplementation to infants.

Zinc supplementation has been shown to benefit linear growth. However the effect may depend on whether zinc is the most limiting nutrient. This study aims to investigate the effect of supplementation with zinc-given alone or with iron and vitamin-A in improving infantsf micronutrient status and linear growth. The study was a double-blind-community-intervention study involving 800 infants aged 3-6 months in rural East Lombok, West Nusa Tenggara. Syrup consisting of zinc-alone, Zn (10 mg/d), zinc+iron, Zn+Fe (10 mg/d of each), zinc+iron+vitamin-A, Zn+Fe+vit.A (10 mg/d of each zinc and iron plus 1,000 IU vitamin-A), or placebo were given daily for six months. Outcomes measured were length, weight, and micronutrient status (haemoglobin, se-rum zinc, ferritin and retinol). Zn+Fe and Zn+Fe+vit.A supplementations benefit zinc and iron status of the sub-jects, while Zn-alone supplementation disadvantaged haemoglobin and iron status. The highest increment in vi-tamin A and haemoglobin status was shown in Zn+Fe+vit.A group. An effect on linear growth was observed among initially-stunted subjects in Zn+Fe and Zn+Fe+vit.A groups who grew 1.1-1.5 cm longer than placebo. On the other hand, in the Zn-alone group, mean height-for-age Z-score decreased to a greater extent than placebo. The between-group difference in HAZ among initially-stunted subjects was significant after four months sup-plementation. While the difference was not significant in follow-up after 6 months, the pattern remained the same where means height-for-age Z-score in Zn+Fe+vit.A and Zn+Fe groups were higher than placebo and Zn-alone groups. Given the low haemoglobin/iron status of the subjects, zinc supplementation would have positive effect on growth if the low haemoglobin/iron status is also addressed and corrected.

ObjectiveThis systematic review commissioned by WHO aimed to synthesise evidence from current literature on the effects of systematically given, routine use of antibiotics for infants under 6 months of age with growth failure/faltering.SettingsLow-income and middle-income countries.ParticipantsThe study population was infants less than 6 months of age with growth failure/faltering.InterventionThe intervention group was infants who received no antibiotics or antibiotics other than those recommended in 2013 guidelines by WHO to treat childhood severe acute malnutrition. The comparison group was infants who received antibiotics according to the aforementioned guidelines.Primary and secondary outcomesThe primary outcome was all-cause mortality, and secondary outcomes: clinical deterioration, antimicrobial resistance, recovery from comorbidity, adverse events, markers of intestinal inflammation, markers of systemic inflammation, hospital-acquired infections and non-response. The Grading of Recommendations Assessment, Development and Evaluation approach was considered to report the overall evidence quality for an outcome.ResultsWe screened 5137 titles and abstracts and reviewed the full text of 157 studies. None of the studies from the literature search qualified to answer the question for this systematic review.ConclusionsThere is a paucity of evidence on the routine use of antibiotics for the treatment of malnutrition in infants less than 6 months of age. Future studies with adequate sample sizes are needed to assess the potential risks and benefits of antibiotics in malnourished infants under 6 months of age.PROSPERO registration numberCRD42021277073.

A 17-month-old girl presented with an upper respiratory tract infections, and was found to have a haemoglobin of 3.3 g/dl. Although noticeably pale, she was largely asymptomatic. Her iron deficiency anaemia was found to be the result of poor diet. With oral iron supplements and improved diet, her haemoglobin increased rapidly, and she is now doing very well.

Background The aim of this open-label, randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic, and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Methods To be included, children aged between 6 months and 2 years are preselected based on mid-upper-arm circumference (MUAC) and are included based on a weight-for-height Z-score (WHZ) between − 3 and − 2 standard deviations (SD). As per current protocols, children receive renutrition treatment for 12 weeks and are assessed weekly to determine improvement. The primary endpoint is recovery, defined by a WHZ ≥ − 1.5 SD after 12 weeks of treatment. Data collected include clinical and socioeconomic characteristics, side effects, compliance and tolerance to interventions. Metagenomic analysis of gut microbiota is conducted at inclusion, 3 months, and 6 months. The cognitive development of children is evaluated in Senegal using only the Developmental Milestones Checklist II (DMC II) questionnaire at inclusion and at 3, 6, and 9 months. The data will be correlated with renutrition efficacy and metagenomic data. Discussion This study will provide new insights for the treatment of MAM, as well as original data on the modulation of gut microbiota during the renutrition process to support (or not) the microbiota hypothesis of malnutrition. Trial registration ClinicalTrials.gov, ID: NCT03474276 Last update 28 May 2018.