View clinical trials related to Gastroenteritis.
Filter by:The trial will be a multinational, randomized, double-blind, double-dummy, endpoint driven, group-sequential, active comparator-controlled study, in which participating infants will be randomized 1:1 to receive either: 1) 90 µg of the TV P2-VP8 vaccine IM plus oral placebo, or 2) Rotarix® per os (PO) plus IM placebo. Participants will receive three doses of TV P2-VP8/placebo IM and two doses of Rotarix®/placebo PO at monthly intervals starting at ≥6 to <8 weeks of age, administered concomitantly with EPI/UIP vaccines. To maintain the blind, infants allocated to the TV P2-VP8 vaccine arm will receive both TV P2-VP8 IM as well as oral placebo vaccine, and infants allocated to receive Rotarix® will receive both Rotarix® PO and placebo IM. Active surveillance for episodes of gastroenteritis (GE) will be conducted throughout the study, through weekly contact with participants' parents. Unsolicited AEs grade ≥ 2 through 28 days after the last study vaccination will be recorded in the study database, as will data for SAEs (including intussusception) throughout the study.
Acute gastroenteritis (AGE) is one of the most common causes of children's morbidity and mortality globally. Oral or intravenous rehydration is the only effective treatment in reducing morbidity and mortality rates in AGE. However, new attempts to identify other therapeutic methods to reduce the symptoms of diarrhea are of interest. The administration of pleuran (β- (1,3 / 1,6) -D-glucan) appears to be such an alternative. In Poland, pleuran is being marketed for treating AGE. Its potential immunomodulatory effect is based on the stimulation of both humoral and cellular immunity. The active substance of the product (pleuran) was extracted by unique and patented technology from Pleurotus ostreatus. The substance was previously isolated, identified and chemically characterized by Karacsonyi and Kunia. Pleuran is registered as a diet supplement and distributed in 20 European and non-European countries. The testing for toxicity was performed by the Institute of Preventive and Clinical Medicine of Slovak Medical University (Final Report No. 5-51/04) and the tests were performed in compliance with the criteria of the Directive of Good Laboratory Practice and Directive 2004/10/EC of the European Parliament and the Council of 11th February 2004. To evaluate the efficacy of pleuran in reducing the duration and the severity of AGE symptoms in children, a randomized, placebo-controlled, fully-blind study has been designed. A total of 120 children will be randomly assigned to receive either Imunoglukan PH4 syrup in the experimental group or matching placebo in the control group. The primary outcome measure will be the duration of diarrhea. The statistical analysis of the results will be conducted in both intention-to-treat and per-protocol approach.
Childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. The aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis.
A phase III, double-blind, parallel-design, randomized, placebo controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge.
40 participants with Eosinophilic Gastritis 12-70 years of age will be randomly assigned with dupilumab or placebo subcutaneous injections every two weeks for a total of 12 weeks. Study subjects who complete the 12-week treatment phase, may continue into an open label extension study, where dupilumab will be administered every two weeks for a total of 24 weeks.
This is a Phase 2, open-label, extension study to assess the safety and tolerability of AK002, given monthly for up to 26 doses.
To compare length of stay (LOS) of pediatric patients in a pediatric emergency room presenting with Gastroenteritis treated with IV rehydration versus oral Speedlyte rehydration.
Evaluation of the impact of the introduction of multiplex PCR panels on the clinical management of patients with gastroenteritis at the University Hospital of Lausanne, Switzerland.
Rotavirus remains among the leading causes of pediatric gastroenteritis requiring hospitalization in the world. Surveillance studies revealed that more than 90% of the global circulating rotavirus strains were predominated by several major genotypes. Clinical trials and post-marketing studies have demonstrated that the currently available rotavirus vaccine can provide sufficient protection against strains of the prevalent genotypes. However, the emerging strains with new genotypes were increasingly reported in the past decade, an ongoing surveillance of the strain changes is needed in the regions where the pediatric population is either fully or partly immunized. In this project, the investigators will setup a hospital-based gastroenteritis surveillance network by incorporating 8 major hospitals in northern, central, southern and eastern Taiwan. From 2013 to 2015, children aged 5 years or younger hospitalized to one of the 8 sentinel hospitals due to acute gastroenteritis will be screened for rotavirus infection, and viral proteins 7 [VP7] (G type) and viral proteins 4 [VP4] (P type) genotypes of rotavirus will be determined for each infected case. The demographics and clinical manifestations of study subjects will also be collected and analyzed. Through this project, the investigators will be able to detect emerging genotypes of rotavirus and delineate the strain distribution during the two years of study in Taiwan. The investigators can also have more comprehensive understanding of the epidemiology of rotavirus regarding to the incidence, disease characteristics, temporal and geographic variations of severe rotavirus gastroenteritis in Taiwanese children. Results from this project will provide valuable information for future implementation of mass immunization against rotavirus in Taiwan.
This is a trial to evaluate the safety and immunogenicity of double mutant heat-labile toxin LTR192G/L211A (dmLT) from Enterotoxigenic Escherichia coli (ETEC) by oral, sublingual, or intradermal vaccination in approximately 135 healthy adult volunteers, age 18-45 years. Study duration is approximately 2.5 years, with each participant duration for up to 9 months depending on the route of dmLT administered. There is no specific hypothesis being tested in this study. The primary objective of this study is to assess the reactogenicity, safety, and tolerability of dmLT when administered in three sequential doses, over a range of dosages by oral, sublingual, or intradermal routes.