Dataset Information

Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12-32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial.

ABSTRACT: Objective: We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children. Design: Randomized, double-blind, placebo-controlled trial. Setting and subjects: Children aged 12-32 months in Japan. Intervention: Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks. Primary endpoint: Prevalence of acute gastrointestinal and respiratory symptom. Results: One hundred nine participants were randomized. Eight participants were lost to follow-up, withdrew consent, or were deemed inappropriate for the trial, with 101 participants receiving complete analyses (placebo group, n = 48; LF group, n = 53). Outcomes: The prevalence of acute gastrointestinal symptoms was significantly less in the LF group (22/53 [41.5%]) than in the placebo group (30/48 [62.5%], p = 0.046). The total number of days having acute respiratory symptoms was significantly lower in the LF group (9.0) than in the placebo group (15.0, p = 0.030). Harms: The rate of adverse events was similar between the groups. No adverse drug reactions were found. Conclusions: LF intake decreased the prevalence of acute gastrointestinal symptoms in children aged 12-32 months.

SUBMITTER: Motoki N

PROVIDER: S-EPMC7249745 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12-32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial.

Motoki Noriko N Mizuki Masaru M Tsukahara Teruomi T Miyakawa Momoko M Kubo Shutaro S Oda Hirotsugu H Tanaka Miyuki M Yamauchi Koji K Abe Fumiaki F Nomiyama Tetsuo T

Frontiers in pediatrics 20200519

Objective: We investigated the effects of lactoferrin (LF)-fortified formula on acute gastrointestinal and respiratory symptoms in children. Design: Randomized, double-blind, placebo-controlled trial. Setting and subjects: Children aged 12-32 months in Japan. Intervention: Intake of placebo or LF (48 mg/day)-fortified formula for 13 weeks. Primary endpoint: Prevalence of acute gastrointestinal and respiratory symptom. Results: One hundred nine participan ...[more]

PMID: 32509712

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Project description:ImportancePneumonia is the leading infectious killer of children. Rigorous evidence supporting antibiotic treatment of children with nonsevere fast-breathing pneumonia in low-resource African settings is lacking.ObjectiveTo assess whether treatment with placebo for nonsevere fast-breathing pneumonia is substantively less effective than 3 days of treatment with amoxicillin.Design, setting, and participantsThis double-blind, 2-arm, randomized clinical noninferiority trial with follow-up of 14 days screened 1343 HIV-uninfected children aged 2 to 59 months with nonsevere fast-breathing pneumonia at outpatient departments of hospitals in Lilongwe, Malawi, Africa, between June 2016 and June 2017.InterventionsPlacebo or amoxicillin dispersible tablets administered twice daily for 3 days.Main outcomes and measuresThe primary end point was the proportion of children failing treatment by day 4 with a relative noninferiority margin of 1.5 times the failure rate in the amoxicillin group. Primary analyses were performed based on the intention-to-treat principle. Planned secondary analyses included treatment failure or relapse by day 14.ResultsIn total, 1126 children were randomized to 3 days of amoxicillin (n = 564) or placebo (n = 562) therapy. Baseline demographic and clinical characteristics were similar between the groups. For the entire study population, the mean (SD) age was 21.3 (15.1) months, and 601 (53.4%) were female. After an interim analysis, the data safety monitoring board stopped the study because children receiving amoxicillin had a 4.0% (22 of 552 with outcome data) treatment failure rate by day 4, whereas children receiving placebo had a 7.0% (38 of 543) treatment failure rate (adjusted relative risk, 1.78; 95% CI, 1.07%-2.97%; adjusted absolute difference, 3.0%; 95% CI, 0.4%-5.7%). Among children with known day 14 outcomes, 56 of 552 (10.1%) receiving amoxicillin and 64 of 543 (11.8%) receiving placebo had either treatment failure by day 4 or relapse by day 14 (relative risk, 1.16; 95% CI, 0.83%-1.63%; absolute difference, 1.6%; 95% CI, -2.1% to 5.4%). There were no deaths.Conclusions and relevanceIn HIV-uninfected children aged 2 to 59 months in a malaria-endemic region of Malawi, placebo treatment of nonsevere fast-breathing pneumonia was significantly inferior to treatment with amoxicillin. However, by day 4, approximately 93% of children receiving placebo were without treatment failure, and there was no significant difference between groups in treatment failure or relapse by day 14. The number of children with nonsevere fast-breathing pneumonia that needed amoxicillin treatment for 1 child to benefit was 33.Trial registrationClinicalTrials.gov Identifier: NCT02760420.

Project description:Human milk provides necessary macronutrients (protein, carbohydrate, fat) required for infant nutrition. Lactoferrin (Lf), a multifunctional iron-binding protein predominant in human milk, shares similar protein sequence, structure, and bioactivity with bovine Lf (bLf). This large-scale pediatric nutrition study was designed to evaluate growth and tolerance in healthy infants who received study formulas with bLf at concentrations within the range of mature human milk.In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 480 infants were randomized to receive a marketed routine cow's milk-based infant formula (Control; n?=?155) or one of two investigational formulas with bLf at 0.6 g/L (LF-0.6; n?=?165) or 1.0 g/L (LF-1.0; n?=?160) from 14-365 days of age. Investigational formulas also had a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) and adjusted arachidonic acid (ARA). The primary outcome was weight growth rate from 14-120 days of age. Anthropometric measurements were taken at 14, 30, 60, 90, 120, 180, 275, and 365 days of age. Parental recall of formula intake, tolerance, and stool characteristics was collected at each time point. Medically-confirmed adverse events were collected throughout the study period.There were no group differences in growth rate (g/day) from 14-120 days of age; 353 infants completed the study through 365 days of age (110; LF-0.6: 127; LF-1.0: 116). Few differences in growth, formula intake, and infant fussiness or gassiness were observed through 365 day of age. Group discontinuation rates and the overall group incidence of medically-confirmed adverse events were not significantly different. From 30 through 180 days of age, group differences in stool consistency (P?<?0.005) were detected with softer stools for infants in the LF-0.6 and LF-1.0 groups versus CONTROL.Compared to the Control, infants who received investigational formulas with bLf and the prebiotic blend of PDX and GOS experienced a softer stooling pattern similar to that reported in breastfed infants. This study demonstrated routine infant formulas with bLf, a blend of PDX and GOS, and adjusted ARA were safe, well-tolerated, and associated with normal growth when fed to healthy term infants through 365 days of age.ClinicalTrials.gov NCT01122654 . Registered 10 May 2010.

Project description:Early iron deficiency has detrimental consequences on neurodevelopment; whether male and female infants are equally susceptible to the functional outcomes of iron deficiency is unclear. This study aimed to investigate the sex differences in the association between serum ferritin levels and neurodevelopment in infants. Data for this cross-sectional study were drawn from hospital information and early childhood development program service systems at Guangdong Women and Children's Hospital, Guangzhou, China. In total, 4579 infants aged 6-12 months were included from July 2018 to March 2020. Their neurodevelopment was assessed using the Children Neuropsychological and Behavior Scale-Revision 2016. Serum ferritin levels were measured by chemiluminescence assay. The association between serum ferritin levels and neurodevelopmental delay in each domain was estimated using logistic regression models adjusted for potential confounders. The mean concentration of serum ferritin was 35.56 ± 21.57 ng/mL. Serum ferritin levels were significantly higher in female than in male infants (P < 0.001). Iron deficiency (serum ferritin levels < 12 ng/mL) was significantly more prevalent in male than in female infants (P < 0.001). Linear regression revealed a positive association between serum ferritin levels and general quotient, gross motor, fine motor, language, and adaptive behavior in females. Iron deficiency was significantly associated with an increased risk of adaptive behavior delay in females (adjusted odds ratio (OR), 2.22; 95% confidence interval (CI): 1.17-4.20). Iron deficiency anemia was associated with an increased risk of developmental delay for general quotient (adjusted OR, 4.88; 95% CI: 1.74-13.65), fine motor (adjusted OR = 2.58, 95%: CI: 1.13-5.94) and adaptive behavior (adjusted OR, 3.38; 95% CI: 1.51-7.57) among females, but not in males. Associations between serum ferritin levels and neurodevelopment in infants aged 6-12 months were sex-related. Females with iron deficiency, especially those with iron-deficiency anemia, were more susceptible to neurodevelopmental delay than males.

Project description:IntroductionIncretin-based therapies, that is, glucagon-like peptide (GLP)-1 receptor agonists and dipeptidyl peptidase (DPP)-4 inhibitors, are relatively novel antihyperglycaemic drugs that are frequently used in type 2 diabetes management. Apart from glucose-lowering, these agents exhibit pleiotropic actions that may have favourable and unfavourable clinical consequences. Incretin-based therapies have been associated with heart rate acceleration, heart failure, acute renal failure and acute pancreatitis. Conversely, these agents may reduce blood pressure, glomerular hyperfiltration, albuminuria and hepatic steatosis. While large-sized cardiovascular safety trials can potentially identify the clinical significance of some of these pleiotropic actions, small-sized mechanistic studies are important to understand the (patho)physiological rationale of these findings. The current protocol describes a mechanistic study to assess cardiovascular, renal and gastrointestinal effects, and mechanisms of incretin-based therapies in type 2 diabetes.Methods and analyses60 patients with type 2 diabetes will undergo acute and prolonged randomised, double-blind, intervention studies. The acute intervention will consist of intravenous administration of the GLP-1 receptor agonist exenatide or placebo. For the prolonged intervention, patients will be randomised to 12-week treatment with the GLP-1 receptor agonist liraglutide, the DPP-4 inhibitor sitagliptin or matching placebos. For each examined organ system, a primary end point is defined. Primary cardiovascular end point is change in resting heart rate variability assessed by beat-to-beat heart rate monitor and spectral analyses software. Primary renal end point is change in glomerular filtration rate assessed by the classic inulin clearance methodology. Primary gastrointestinal end points are change in pancreatic exocrine function assessed by MRI-techniques (acute intervention) and faecal elastase-1 levels (12-week intervention). Secondary end points include systemic haemodynamics, microvascular function, effective renal plasma flow, renal tubular function, pancreatic volume and gallbladder emptying-rate.Medical ethics and disseminationThe study is approved by the local Ethics Review Board (VU University Medical Center, Amsterdam) and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice.Trial registration numberNCT01744236.

Dataset Information

Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12-32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial.

Publications

Effects of Lactoferrin-Fortified Formula on Acute Gastrointestinal Symptoms in Children Aged 12-32 Months: A Randomized, Double-Blind, Placebo-Controlled Trial.

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