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NCT05992935
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
NCT07342088
This randomized controlled trial evaluated the effect of a combination of Lactobacillus acidophilus DSMZ 26280 and Limosilactobacillus reuteri DSMZ 25441 on the duration of diarrhea and gut microbiota composition in children aged 1-6 years with acute infectious diarrhea.
NCT06516692
This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available. Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
NCT06038305
1. Assessment of the growth parameters in infants admitted with acute gastroenteritis. 2. Determine the prevalence of anemia in infants admitted with acute gastroenteritis.
NCT05270291
In children with acute gastroenteritis (AGE), vomiting often precedes diarrhea. To establish the diagnosis of AGE, enteropathogen detection typically relies on diarrheal stool samples. However, testing requires sufficient stool sample, which may not be easily available. Recent studies suggest that in children presenting to emergency departments with presumed AGE with isolated vomiting, an enteropathogen can be identified using rectal swabs and molecular diagnostic tests. The rate of enteropathogen detection in children with isolated vomiting due to AGE may differ in various populations. Using rectal swabs and molecular diagnostic tests, we plan to assess the proportion of children with isolated vomiting with presumed AGE in whom an enteropathogen can be identified. This will be a prospective cohort study. Children younger than 5 years with presence of ≥3 episodes of vomiting due to presumed AGE, lasting no longer than 7 days before enrolment, will be recruited. A total of 198 participants will be recruited and a rectal swab will be collected. The participants will be contacted 14 days after enrollment to complete a survey regarding symptoms experienced during that period and to identify any additional clinical care.
NCT02902445
The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.
NCT05213325
Cytokines, such as IL-6 and IL-8 can be used as markers of acute infections, including acute gastroenteritis. This study aims to evaluate serum levels of interleukins 6 and 8 in children with acute gastroenteritis.
NCT04682860
One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.
NCT05076461
Most of the trials conducted comparing ondansetron and domperidone have been conducted among children aged below 5 or 6 years of age while no study from Pakistan has compared efficacy of these antiemetic agents among children up to 12 years of age. The findings of present study will give valuable evidence about the effectiveness of these antiemetic agents to prevent vomiting among children suffering with acute gastroenteritis at a resource limited setting of South Punjab, Pakistan.
NCT03234777
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.
NCT02246010
The purpose of this study is to determine whether lactose-free milk will shorten the diarrhea duration and decrease its severity in formula-fed infants presenting to the Emergency Department (ED) or pediatric clinics with acute diarrhea.
NCT03021109
The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis
NCT00973284
The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during the inpatient stay.
NCT02025452
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. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.
NCT01737086
Oral rehydration solution (ORS) is recommended for treatment and prevention of dehydration due to acute gastroenteritis in infants and children. Acute diarrhoea leads to zinc depletion in infants, and zinc is recommended by the World Health Organization in the treatment of acute gastroenteritis in infants and children. However, the efficacy of zinc supplementation to children with acute gastroenteritis in more affluent settings is unclear. Selected strains of probiotics, including L. reuteri ATCC 55730, have been shown in several studies to shorten the duration of diarrhoea by about 24 hours, and also to attenuate symptom severity. If probiotics are given within 60 hours from onset of symptoms the duration can be reduced even more. Lactobacillus reuteri (L. reuteri) has been shown to reduce the duration and severity of acute gastroenteritis in children aged 6-36 months. In these studies L. reuteri was proven to have clinical effect on diarrhoea of both bacterial and viral (rotavirus) origin. In humans, L. reuteri strain DSM 17938 has recently been shown to reduce the duration of watery diarrhoea by 1.2 days among 6-36 mo old Italian children with acute gastroenteritis treated in hospital. The present, community-based study aims to assess if an ORS with Lactobacillus reuteri DSM 17938 and zinc can be superior or equivalent to ORS without probiotic and zinc in reducing the duration of acute gastroenteritis in children aged 6-36 months, with no, mild or moderate dehydration when introduced early (within 48 hours) after the start of gastroenteritis associated diarrhoea in an out-patient setting. A prospective, randomized, double blind, controlled study with parallel groups will be performed. Assuming a difference of 25% between groups in the primary outcome of prevalence of diarrhoea 48 hours after start of treatment (80% power, alfa = 5%), and estimating an attrition rate of approximately 15%, the final sample size will be 142 subjects, or 71 subjects in each arm. Parents contacting the health care telephone enquiry agency, the primary care emergency unit, the paediatric emergency unit, all at the Umeå University Hospital or the well-baby care centres (BVC) in Umeå for advice on their children's gastroenteritis will be informed that they may participate in the present study and they will be given contact information to the research nurse for this activity. A home visit by study personnel will then be done for evaluation of eligibility, information, collection of informed consent and delivery of study product. Data collection points will be at the recruitment visit in the patient's home, and by telephone on day 7. If the child still has gastrointestinal symptoms on day 5 it will be referred to the primary health care facility or the outpatient clinic of the Department of Paediatrics, Umeå University Hospital.
NCT02169817
Primary Objective: To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in the duration of acute community-acquired diarrhea in Latin American children. Secondary Objectives: To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting episodes. To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of Enterogermina in norovirus acute gastroenteritis (AGE).
NCT02367612
Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo. Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.
NCT01564290
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.