SUMMARY BackgroundProblems with currently recommended Helicobacter pylori eradication therapies include unsatisfactory eradication rates and ⁄ or therapy-associated side effects.
The lack of a significant difference between the formula-fed groups in growth, or the occurrence of serious adverse events, supports the safety of using IF supplemented with synbiotics. Further studies are needed to evaluate the effects of such formula on lower-respiratory tract infections.
Autism spectrum disorders (ASD) are caused by disruptions in early stages of central nervous system development and are usually diagnosed in first years of life. Despite common features such as impairment of socio-communicative development and stereotypical behaviours, ASD are characterised by heterogeneous course and clinical picture. The most important aetiological factors comprise genetic and environmental influences acting at prenatal, perinatal and neonatal period. The role of rare variants with large effect i.e. copy number variants in genes regulating synapse formation and intrasynaptic connections is emphasised. Common variants with small effect may also be involved, i.e. polymorphisms in genes encoding prosocial peptides system - oxytocin and vasopressin. The environmental factors may include harmful effects acting during pregnancy and labour, however their specificity until now is not confirmed, and in some of them a primary genetic origin cannot be excluded. In several instances, especially with comorbid disorders - intellectual disability, epilepsy and dysmorphias - a detailed molecular diagnostics is warranted, which currently may elucidate the genetic background of disorder in about 20% of cases.
Introduction
Acute gastroenteritis is one of the most common causes of children’s
morbidity and mortality globally. Oral or intravenous rehydration was
proven effective in reducing the mortality rates in acute
gastroenteritis, although it does not affect the course of the disease.
Attempts to identify new therapeutic methods effective in reducing the
symptoms of diarrhoea are of interest. Pleuran’s potential
immunomodulatory effect in acute gastrointestinal infection relies on
the stimulation of innate immunity. The effectiveness of pleuran
(β-(1,3/1,6)-d-glucan) administration to treat acute infectious
diarrhoea remains unknown. This study evaluates the efficacy of pleuran
in reducing diarrhoea duration and the severity of acute gastroenteritis
symptoms in children.
Methods and analysis
Our study is a randomised, double-blind, placebo-controlled
superiority trial with two parallel groups and a 1:1 allocation ratio. A
total of 120 children aged 2–10 years hospitalised or requiring a visit
to the emergency department because of acute gastroenteritis will be
randomly assigned to receive either pleuran oral suspension in the
experimental group or matching placebo in the control group. The primary
outcome measure will be the duration of diarrhoea. We will analyse the
results in both intention-to-treat and per-protocol approaches.
Ethics and dissemination
The Bioethics Committee of The Medical University of Warsaw approved
the study protocol (approval number: KB/45/2018). Written informed
consent of the patients’ caregivers participating in the study will be
obligatory. The results of this study will be published in a medical
journal, regardless of whether they confirm or deny the research
hypothesis.
Trial registration number
NCT03988257; Pre-results.
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