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Gastroenteritis clinical trials

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NCT ID: NCT03539913 Completed - Clinical trials for Acute Gastroenteritis

Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

SABINA
Start date: June 19, 2017
Phase: Phase 4
Study type: Interventional

- Primary Objective: o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis. - Secondary Objectives: - To assess the efficacy of the probiotics in improving the frequency and consistency of stools. - To assess the efficacy of the probiotics in avoiding recurrence of diarrhea. - To assess the efficacy of the probiotics on the disease severity. - To assess the safety and tolerability of the studied probiotics.

NCT ID: NCT03496571 Completed - Clinical trials for Eosinophilic Gastroenteritis

A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis

ENIGMA
Start date: July 18, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2, double-blind, randomized, placebo-controlled study to assess the effects of AK002, given monthly for 4 doses. It is hypothesized that AK002 is more effective than placebo control (alternative hypothesis) in reducing the number of eosinophils per high power field (HPF) in gastric and/or duodenal biopsies before and after receiving AK002 or placebo versus no difference between AK002 and placebo control (null hypothesis).

NCT ID: NCT03474055 Completed - Clinical trials for Rotavirus Gastroenteritis

Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India

Start date: October 30, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.

NCT ID: NCT03473977 Completed - Clinical trials for Eosinophilic Gastritis or Gastroenteritis

Benralizumab for Eosinophilic Gastritis (BEGS)

BEGS
Start date: April 23, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Benralizumab (Anti-IL5RA) in Subjects With Eosinophilic Gastritis.

NCT ID: NCT03395405 Completed - Clinical trials for Gastroenteritis Norovirus

NNITS-Nitazoxanide for Norovirus in Transplant Patients Study

Start date: October 15, 2018
Phase: Phase 2
Study type: Interventional

This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to Norovirus. The study involves a total of 160 Hematopoietic Stem Cell or Solid Organ transplant recipients, equal to or greater than 12 years of age with diagnosis of Norovirus who will be selected and randomly assigned (1:1) to nitazoxanide or placebo group. The study duration is 60 months and subject participation duration is 6 months. Given the safety of prolonged therapy with nitazoxanide, lack of interactions with common post-transplant medications, putative antiviral activity and prolonged duration of viral shedding we are assessing 56 doses of therapy. The longitudinal monitoring phase will provide useful information on the course of host and viral responses in subjects with chronic Norovirus infection with and without treatment. Randomization will be stratified by age group (pediatric (12 through 17 years) vs. adult (greater than or equal to 18 years)), chronicity of Norovirus-associated symptoms (acute (less than 14 days) vs. chronic (greater than or equal to 14 days)) and transplant type (solid organ (SOT)) vs. hematopoietic stem cell transplant (HSCT)). Enrolled subjects will participate in 2 phases of the study: Treatment Phase, which will include dosing with the assigned study agent for 28 days. Longitudinal Monitoring Phase which will include telephone call on Days 35, 53, 113, 173. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients.

NCT ID: NCT03357237 Recruiting - Diarrhea Clinical Trials

EFFICACY AND SAFETY OF XILOGLUCAN IN ACUTE GASTROENTERITIS IN CHILDREN

PEDXIL01
Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Acute gastroenteritis (GEA) is an inflammation of the intestinal mucosa that clinically translates into an acute episode of diarrhea and vomiting and is generally associated with an intestinal infectious disease. It is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. The important loss of liquids can lead to dehydration, acidosis and hydroelectrolitic alteration. Infants are more vulnerable to gastrointestinal infection and its consequences, dehydration and malnutrition. There is no specific treatment, so it is exclusively symptomatic A new type of products considered as mucoprotectors has been developed, such as gelatin tannate or xyloglucan, still with little data to establish recommendations on its use in the GEA. They would be able to reproduce in the intestine a muco-adhesive film or sheet protective It must be considered in this sense that mucus is the first barrier that protects the gastrointestinal tract against microorganisms or antigens and that bacterial invasion is related to the opening of narrow junctions. Xyloglucan was approved in Europe as a medical device IIa to restore the physiological functions of the intestinal wall in the form of capsules for adults and envelopes for children.

NCT ID: NCT03320369 Completed - Clinical trials for Eosinophilic Gastroenteritis

Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Start date: September 5, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

NCT ID: NCT03294772 Completed - Clinical trials for Respiratory Tract Infections

Impact of a Multifactorial Program of Hand Hygiene on Infections in Children Attending in Day-care Centres

Start date: November 1, 2013
Phase: N/A
Study type: Interventional

It is well known that attending Day Care Centres (DCCs) can lead to an increase in the frequency of infections, due to the high incidence at this age and also the ease of transmission among children. This high incidence respiratory tract infections (RTIs) and acute gastroenteritis can also have a significant impact on the cost of health care systems, increasing the number of medical visits, hospitalizations and prescribing medications as symptomatic drugs or unnecessary antibiotics in some cases.The aim of the study was to determine whether a multifactorial hand-hygiene program (handwashing with soap and water vs hand sanitizer vs control group) reduce episodes due to RTIs and gastroenteritis in children attending DCCs. In addition, analyze the cost-effectiveness of these interventions.

NCT ID: NCT03271593 Completed - Gastroenteritis Clinical Trials

Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study

Start date: November 2, 2015
Phase: N/A
Study type: Observational

The impact of rotavirus vaccination on the burden of disease has been well documented. However, the anticipated reduction in hospital pressures has yet to be described. This study will provide quantitative measures of hospital pressure prior to and post vaccine introduction, provide a template for future hospital pressures studies related to vaccine introduction and provide measures which could be used in an economic evaluation.

NCT ID: NCT03234777 Completed - Pediatric ALL Clinical Trials

Evaluating a Knowledge Translation Tool for Parents

Start date: November 30, 2017
Phase: N/A
Study type: Interventional

Diarrhea and vomiting in children is a common reason to visit the emergency department. There has been a lot of research on how best to treat children with diarrhea and vomiting who visit the emergency department; however, the care children receive varies by healthcare provider and across hospitals. Additionally, there are things parents can do at home to help manage childhood diarrhea and vomiting and potentially avoid a trip to the emergency department. This shows an urgent need for knowledge translation, that is, efforts to align research knowledge and healthcare practice. Actively involving parents in healthcare decisions has the potential to bridge this gap; however, there is little research on the best ways to communicate complex health information to parents of sick kids. In 2013, a national needs assessment was conducted with parents seeking care for their kids in general emergency departments (trekk.ca). This survey showed that 39% of parents looked for information about their child's health prior to coming to the emergency department and that 44% of these parents looked for this information on the internet. This means that the development and evaluation of digital tools to give parents timely and effective child health information has the potential to reduce unnecessary emergency department visits, empower parents in health decision-making, and ultimately improve child health outcomes. In this project, parents will be actively involved in the evaluation of a digital tool, a whiteboard animation video, designed to communicate the best research evidence on the treatment and management of vomiting and diarrhea in children. In this pilot trial, parents in two emergency departments will be randomized to view the video or a sham video, and then provide quantitative and qualitative data on the potential effectiveness of the video, the perceived benefit and value of the knowledge translation intervention for pediatric vomiting and diarrhea, the feasibility of using iPads and an electronic data collection platform to conduct research with this population, the time required to complete data collection, and parents' willingness to participate in future, similar research.