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Gastroenteritis clinical trials

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NCT ID: NCT01199874 Completed - Clinical trials for Rotavirus Gastroenteritis

Immunogenicity of Rotavirus Vaccine

Start date: April 2011
Phase: Phase 4
Study type: Interventional

Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and Rotateq® were licensed in many high and middle income countries in 2006, but lack of efficacy data in low income countries had prevented WHO from making a universal recommendation of their use until recently. This study will be conducted in Pakistan and will look at two objectives: 1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks of life and at 6, 10 and 14 weeks of life. 2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of vaccine administration with infants whose breast feeding is withheld for one hour before and after vaccine administration.

NCT ID: NCT01198587 Completed - Diarrhea Clinical Trials

Oral Zinc for the Treatment of Acute Diarrhea in US Children

Start date: November 2010
Phase: N/A
Study type: Interventional

Diarrheal diseases are the third leading cause of mortality in the world, with nearly 2 million deaths annually among children under age 5 years. Several clinical trials of oral zinc supplementation performed in developing country populations have confirmed this nutrient's efficacy in reducing the severity and frequency of diarrhea. The World Health Organization (WHO) has recommended global use of zinc supplementation in all children with diarrhea despite little or no data from trials in industrialized/developed settings. In the United States over 4 million children suffer annually from diarrheal illness. Although mortality is not a significant factor in U.S. cases, 75% of all cases present to medical care resulting in over 200,000 hospitalizations annually for diarrhea. This has significant impact on U.S. healthcare costs, with an average of $391 per outpatient treatment and $2,549 per inpatient treatment spent on each episode of acute diarrheal illness. The goal of this study is to evaluate the effectiveness of oral zinc in decreasing the duration of diarrhea in children treated as outpatients and in decreasing the duration of hospitalization in children treated as inpatients in an industrialized country. The results of this study promise to have a substantial impact on the management of a common pediatric health problem, and could conceivably affect direct and indirect healthcare costs to society.

NCT ID: NCT01185054 Completed - Gastroenteritis Clinical Trials

Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The objective of this study is to clarify the current standard of care by determining if Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk children who present to an Emergency Department (ED) with < 72 hours of vomiting or diarrhea.

NCT ID: NCT01177826 Completed - Clinical trials for Infections, Rotavirus

Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children

Start date: February 23, 2008
Phase:
Study type: Observational

The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.

NCT ID: NCT01177657 Completed - Clinical trials for Rotavirus Gastroenteritis

Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil

Start date: May 2008
Phase: N/A
Study type: Observational

The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.

NCT ID: NCT01175252 Completed - Gastroenteritis Clinical Trials

Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil

Start date: December 2008
Phase: N/A
Study type: Observational

This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.

NCT ID: NCT01171144 Completed - Gastroenteritis Clinical Trials

Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama

Start date: January 2009
Phase: N/A
Study type: Observational

This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children < 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.

NCT ID: NCT01168401 Completed - Gastroenteritis Clinical Trials

Bivalent Norovirus Vaccine Study

Start date: September 3, 2010
Phase: Phase 1
Study type: Interventional

Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart. The hypotheses for this study are: - The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and Al(OH)3. - Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose. - The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.

NCT ID: NCT01165866 Completed - Gastroenteritis Clinical Trials

Ondansetron Versus Metoclopramide in Treatment of Vomiting in Gastroenteritis

Start date: June 2008
Phase: Phase 4
Study type: Interventional

Is intravenous metoclopramid as effective as intravenous ondansetron in the treatment of persistent vomiting in patients with acute gastroenteritis.

NCT ID: NCT01147445 Completed - Clinical trials for Gastroenteritis Escherichia Coli

Phase I Study of ETEC Vaccine

Start date: September 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn if a new candidate vaccine (dmLT) against ETEC (E. coli infection) is safe. This vaccine will be tested to see what effects it has on the body and the ability of the vaccine to help the body resist disease. Researchers want to find the highest dose of dmLT vaccine that can be given without causing severe side effects. Most E. coli bacteria are harmless to humans and can even be beneficial. However, some are harmful, and can cause diarrhea. About 32 healthy adults, ages 18-45, will participate in this study. This study will require volunteers to stay in the research facility for several nights. Participants will be assigned to receive 1 of 4 vaccine doses by mouth. Study procedures include: stool samples, blood samples, and documenting side effects. Participants will be involved in study related procedures for about 8 months.