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Gastroenteritis clinical trials

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NCT ID: NCT02868073 Completed - Clinical trials for Norovirus Gastroenteritis

Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine

Start date: July 29, 2016
Phase: Phase 1
Study type: Interventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant Administered Orally to Healthy Volunteers

NCT ID: NCT02855463 Recruiting - Gastroenteritis Clinical Trials

Study of Giant Viruses of Amoebas Infections in Children Suffering From Gastroenteritis

Start date: July 2011
Phase: N/A
Study type: Observational

The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial origin or cellular proteins This project focuses on the detection and analysis of new viral agents (viruses and virophages giant amoeba environmental) and their involvement in human pathology. The objectives of this study are observational: detect and document the presence of giant viruses and virophages of amoebae in the faeces of children presenting to the pediatric emergency reception service of the North Hospital in AP -HM with or without clinical evidence of gastroenteritis.

NCT ID: NCT02803827 Completed - Clinical trials for Acute Gastroenteritis

Optimizing the Management of Acute Diarrhoeal Disease

Start date: June 2016
Phase: Phase 3
Study type: Interventional

Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. The investigators will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. The investigators will also be randomizing children to Lactobacillus reuteri DSM (daughter strain) 17938 therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a large multi-centre trial following the previous pilot trial.

NCT ID: NCT02756221 Completed - Gastroenteritis Clinical Trials

Probiotic Supplementation and Endurance Performance in Cyclists and Masters Runners

Start date: March 2016
Phase: N/A
Study type: Interventional

The study will evaluate the change in gastrointestinal (GI) flora following probiotic supplementation, and expected to lead to an increase in the intestinal epithelial integrity and to improvement in its health. Concurrently with the reduction in the amount of toxins in the GI tract following an intensive exercise, a lower incidence of symptoms of discomfort will improve the quality of the training sessions which will be exhibited by an improvement in endurance capacity and in physiological responses to rigorous exercise. Half of the participants will receive probiotic supplement while the other half will receive a placebo.

NCT ID: NCT02729870 Withdrawn - Ketosis Clinical Trials

Oral Glucose Intervention for Children With Gastroenteritis and Ketosis

Start date: January 2018
Phase: N/A
Study type: Observational

Fasting ketoacidosis adds morbidity to children affected by gastrointestinal infections. The investigators investigate oral glucose gel for its effectiveness in rapidly reducing ketoacidosis and for improvements in oral hydration therapy success.

NCT ID: NCT02728869 Completed - Clinical trials for Rotavirus Gastroenteritis

Safety, Reactogenicity and Immunogenicity of Heat-stable Rotavirus Vaccine (HSRV) in Adults and Infants

HSRV
Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Rotaviruses are the leading cause of severe, dehydrating diarrhoea and related deaths in children aged less than 5 years worldwide and are reported to infect nearly every child by the age of 5 years. About 90% of all rotavirus-associated fatalities occur in low income countries in Africa and Asia and are related to poor health care. In view of high global RVGE burden, the World Health Organization (WHO) on 5th June 2009, recommended the inclusion of rotavirus vaccine in all the national immunization programs. Currently available rotavirus vaccines, RotaTeq® and Rotarix®, are WHO prequalified vaccines which are stable for recommended duration at storage temperature between 2-8 °C. However, if these vaccine are exposed to temperatures above 30 °C, the vaccine has to be discarded due to lost potency. It is very difficult to maintain the cold chain required to conserve the vaccine potency particularly in developing and low income countries, resulting in large amount of vaccine being wasted and in worst case scenario, endangering the lives of potential recipients. The WHO estimates that nearly half of freeze-dried and quarter of liquid vaccines are wasted each year. One of the biggest contributors to this wastage is disruption of the cold chain systems. Hilleman Labs new Rotavirus vaccine is a lyophilized heat stable rotavirus vaccine comprising of five live attenuated reassortant rotaviruses similar to RotaTeq®. The new heat stable rotavirus vaccine (HSRV) formulation offers a stability profile of 9 months at 45 °C and 12 months at 37 °C. This new heat stable formulation (HSRV) could be transported in non-refrigerated supply chain significantly reducing the cost and complications associated with transporting vaccine to remote corners of the developing world. Heat-stable rotavirus vaccine (HSRV) has a potential to sustain high temperatures frequently encountered in regions where majority of rotavirus burden exists and has potential to partially or completely eliminate cold chain dependence. The current study has been designed to test for the first time in humans, the safety and tolerability of the new heat stable rotavirus vaccine (HSRV) in adults; followed by safety and immunogenicity in infants of age 6-8 weeks, as compared to the licensed RotaTeq® vaccine.

NCT ID: NCT02711241 Terminated - Gastroenteritis Clinical Trials

Optimal Analgesia in Acute Gastroenteritis

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study

NCT ID: NCT02701491 Completed - Nausea Clinical Trials

Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The acute gastroenteritis is a very common problem in children. The frequency and duration of this condition involves a high discomfort for the child and his family, and significant costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of the cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use and hospitalization. To limit vomiting and facilitate oral rehydration have been proposed several pharmacological strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and side effects (ondansetron and metoclopramide) and therefore contraindicated in patients of pediatric age. The administration of some medicinal herbs is able to induce an effective anti-emetic power. Among the various types of plants studied, the rhizome of Zingiber officinale, commonly known as ginger is used as an antiemetic in various traditional systems of medicine for over 2000 years. There are several scientific evidence on the beneficial properties of ginger, including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and in pregnant. A recent meta-analysis has confirmed that ginger is effective in non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy. To date there are several formulations of the ginger on the market in Italy, and their use is fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the absence of clinical evidence of efficacy. The purpose of the proposed study is to demonstrate the effectiveness of treatment with ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.

NCT ID: NCT02699385 Terminated - Gastroenteritis Clinical Trials

A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis

Start date: December 7, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric participants with AG and mild-to-moderate dehydration.

NCT ID: NCT02685527 Completed - Gastroenteritis Clinical Trials

Acute Gastroenteritis: Development of PCR Analysis and Algorithm for Fast Clarification of Isolation Indication

Start date: February 2015
Phase: N/A
Study type: Observational

Isolation of contagious patients is expensive, requires more caregiver time, most of the patients perceive isolation as a mental strain and it has been shown that the level of care and observation is lower than in a normal ward. But isolation of contagious patients is necessary to protect other patients, hospital staff and relatives to prevent spreading of infection and, in worst case out-break. There are different isolation regimes available depending on causative agent and mode of transmission. A community-acquired acute gastroenteritis (GE) is most often caused by Norovirus while a hospital-acquired acute GE is often caused by toxin producing Clostridium difficile. Patients infected with Norovirus or Clostridium difficile have to be isolated in single rooms with strict contact precautions. Patients infected with acute GE caused by other pathogens can be isolated in a multi-bed room if there is a private toilet. However, at the time of arrival to hospital it is not known if the patient is contagious. The indication of isolation has to be made based of a clinical evaluation in risk of isolating to few or too many patients. Aim of the study: To identify anamnestic, clinical and paraclinical variables that can be used as indicators of the aetiology of infectious GE, thus giving an indication for isolation. To clinically evaluate a combined RNA (Norovirus) and DNA (Clostridium difficile) fast PCR analysis test to identify infectious GE compared to gold standard methods.