Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants...
Rotavirus InfectionsRotavirus GastroenteritisThe purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
IL6&8 in Malnourished Children With Acute Diarrhea
Acute DiarrheaSevere Acute Malnutrition1 moreCytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. However, there have been no previous studies on the levels of IL-6 and IL-8 in malnourished children with acute diarrhea. This study aims to evaluate serum levels of interleukins 6 and 8 in malnourished children with acute diarrhea.
Examining the Effect of Ondansetron on Bowel Prep Success
Abdominal PainInflammatory Bowel Diseases4 moreThis is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.
Evaluation of Serum Interleukin 6 and 8 in Children With Acute Gastroenteritis
Acute GastroenteritisAcute DiarrheaCytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.
Eosinophilic Gastrointestinal Disorders Registry
Eosinophilic EsophagitisEosinophilic Gastroenteritis2 moreThe purpose of this study is to learn more about Eosinophilic Gastrointestinal Disorders (EGIDs). With this registry we hope to find out more about the symptoms that patients have during their treatment, the quality of life they have with the diagnosis, what the disease looks like throughout the different treatment methods, and if there is a connection between EGIDs and connective tissue disorders. The goal of this study is to be able to better understand EGIDs and use information gained from all the information collected on this study for more precise treatments in the future. We want to create a large collection of samples, called a biorepository, to learn the most about EGIDs as possible. When the samples are collected, which will occur at procedures directed by your child's doctor as part of their standard of care, they will be stored for an unlimited amount of time to perform experiments on these samples and to gather information about EGIDs
Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
Acute GastroenteritisThe purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).The test vaccine contains recombinant HuNoV GI.1-VP1 protein, HuNoV GII.3-VP1 protein, HuNoV GII.4-VP1 protein, HuNoV GII.17-VP1 protein, and each dose contains 12.5μg/type/0.5ml/bottle (Low dose), 25μg/type/0.5ml/piece (high dose).
This Study Will Assess the Efficacy and Safety of Ondansetron Compared to Metoclopramide in the...
GastroenteritisA Randomized, Open-label, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Ondansetron compared to Metoclopramide in the management of Nausea and Vomiting in Adult Patients with Acute Gastroenteritis.
Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant...
Norovirus InfectionsNorwalk GastroenteritisThe purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic...
Eosinophilic Gastrointestinal DisordersEosinophilic Esophagitis2 moreEosinophilic gastrointestinal disorders (EGIDs) are a heterogeneous group of emerging chronic inflammatory diseases that may affect different gastrointestinal (GI) tracts. Based on the anatomical site involved, EGIDs are distinguished into eosinophilic esophagitis (EoE) and non-esophageal forms, which are subdivided into eosinophilic gastritis (EoG), gastroenteritis (EoGE), and colitis (EoC). EoE is considered the prototype of EGIDs. Since the first description of a case series of patients with EoE, fundamental scientific advances have been achieved, culminating in the redaction of international diagnostic and therapeutic guidelines. In contrast to EoE, non-esophageal forms of EGIDs are still a clinical enigma with evidence limited to a few retrospective studies. In the last decade, an increase in the prevalence of EGIDs has been observed in the pediatric age. Unfortunately, the epidemiology of EGIDs in Italy is still inconsistent and clear estimates are not available. Firstly, this study will allow us to assess and clarify several clinical and epidemiological aspects of pediatric EGIDs, in particular: prevalence and incidence of pediatric EGIDs in Italy, the clinical features and potential phenotypes of pediatric EGIDs with potential impact on therapy and management, diagnostic work-up and adherence to the EoE international guidelines to improve the management, quality of care, and quality of life of affected patients. This study has no ethical problems since EoE patients are treated according to international guidelines and those with non-esophageal EGIDs according to the latest scientific evidence.
Pediatric and Ambulatory Research in Infectious Diseases
OtitisBronchiolitis5 moreMany ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.