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Gastroenteritis clinical trials

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NCT ID: NCT01733862 Completed - Clinical trials for Infections, Rotavirus

Study to Assess the Impact of Vaccination on Hospitalizations and Outpatient Visits Due to Rotavirus Gastroenteritis

Start date: November 27, 2012
Phase:
Study type: Observational

This study aims at assessing the impact of RV vaccination in hospitals in Nagoya City (administrative district), Japan, where RV vaccines have been introduced since November 2011 and financial support for vaccination costs by Nagoya city, Japan have been implemented from October 2012.

NCT ID: NCT01733849 Completed - Clinical trials for Infections, Rotavirus

A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

Start date: December 2012
Phase: N/A
Study type: Observational

This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.

NCT ID: NCT01709266 Completed - Diarrhea Clinical Trials

The Effect of Probiotics on E. Coli-induced Gastroenteritis

PROTETEC
Start date: August 2012
Phase: N/A
Study type: Interventional

Background: The incidence of gastrointestinal infections is very high. In Western countries at least 30% of the population suffers from at least one food-borne infection per year. Mostly because of the problem of antibiotic resistance, more emphasis is put on prevention of infections. One of the possibilities is to strengthen human resistance to gut infections by consumption of probiotics. A specific blend of probiotic lactic acid bacteria (Lactobacillus helveticus Rosell-52, Lactobacillus rhamnosus Rosell-11, Bifidobacterium longum Rosell-175) and a probiotic yeast (Saccharomyces boulardii), improved stool consistency and shortened the duration of diarrhea in a rat model of E.coli-induced diarrhea. These probiotics showed synergistic effects compared with administration of solely S. boulardii or a mixture of L. helveticus Rosell-52, L. rhamnosus Rosell-11, B. longum Rosell-175. Consumption of S. boulardii and a combination of L. helveticus Rosell-52, L. rhamnosus Rosell-11 reduced diarrhea in humans. Aim: To study whether probiotics improves the resistance of humans to enterotoxigenic E. coli (ETEC). Study design: The PROTETEC study is a parallel, double-blind, placebo-controlled 4-weeks intervention with probiotics in healthy volunteers. In this study, the effect of probiotic intervention vs placebo on several infection markers in response to an ETEC challenge is investigated. Participants will be randomly assigned to the probiotic or placebo group (n=30 per group). Subjects will be instructed to maintain their usual pattern of physical activity and their habitual food intake, but to standardize their dietary calcium intake. After an adaptation period of 2 weeks, subjects will be orally infected with a live, but attenuated, ETEC vaccine (strain E1392-75-2A; collection NIZO food research; dose 10E10 CFU). Before and after infection, a diary will be kept to record all food and drinks consumption (2x2 days) to assess the habitual dietary intake, as well as for daily recording of bowel habits and frequency and severity of gastrointestinal complaints. The following biological samples will be collected: 4x10 ml venous blood, a single fecal bolus (for screening) and 7x24 hrs feces. Blood is sampled for immune response analyses and the fecal samples are collected to quantify several infection- and immune system markers, to determine probiotic excretion, and to verify dietary calcium intake. Study population: Healthy males of 20-55 yrs of age. Interventions: Probiotics (capsules containing freeze-dried powder, probiotic dose per capsule 5x10E9 CFU; twice daily) or placebo (capsules with carrier material powder of identical appearance) Primary outcomes: Fecal ETEC excretion and severity of diarrhea (quantified by fecal output per day). Secondary outcomes: Serum immune response to ETEC, self-reported stool consistency scores and gastrointestinal complaints, relative fecal wet weight. Tertiary outcomes: sIgA and calprotectin in feces, probiotic persistence and levels of opportunistic pathogens in the endogenous microbiota.

NCT ID: NCT01657032 Completed - Diarrhea Clinical Trials

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

NCT ID: NCT01600092 Completed - Clinical trials for Rotavirus Gastroenteritis

A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)

Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.

NCT ID: NCT01577043 Completed - Clinical trials for Acute Gastroenteritis

Efficacy of Racecadotril in Acute Watery Diarrhea in Children

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

The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.

NCT ID: NCT01575197 Completed - Clinical trials for Rotavirus Gastroenteritis

Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.

NCT ID: NCT01571856 Completed - Clinical trials for Acute Gastroenteritis

Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants

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

The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.

NCT ID: NCT01564290 Completed - Clinical trials for Acute Gastroenteritis

Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children

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

The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.

NCT ID: NCT01508533 Completed - Clinical trials for Rotavirus Gastroenteritis

Epidemiology of Rotavirus Infection in North India Community

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

This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.