
Pathogen-microbiome Interaction During Helicobacter Pylori Infection
Helicobacter Pylori InfectionHelicobacter pylori affects the gut microbiome in ways that are only partially understood. In which patients H. pylori causes severe disease and in whom it merely colonizes, possibly even with beneficial effects, is not understood. The investigators are pursuing the hypothesis that changes in the gut microbiome that can be easily measured in stool have such predictive value.

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to...
SARS-CoV-2 InfectionA multicenter, randomized, double-blinded, placebo-controlled, phase 3 clinical efficacy study evaluating nitric oxide nasal spray (NONS) as prevention for treatment of individuals at risk of exposure to COVID-19 infection.

Efficacy and Safety of 14-day Concomitant Therapy for Refractory Helicobacter Pylori Infection
Helicobacter Pylori InfectionThe purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.

Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections...
Urinary Tract InfectionsThe aim of this clinical trial is to determine, in children with multi-drug resistant urinary tract infections, whether oral fosfomycin is noninferior to standard of care antibiotics in achieving a cure without recurrence within 30 days of treatment. The The main questions the trial aims to answer are: Is oral fosfomycin inferior in efficacy to the current standard to care for multi-drug resistant UTIs in children as defined by the recurrence of a UTI within 30 days of completion of therapy? Is fosfomycin a safe and well-tolerated antibiotic in children? Participants aged ≥1 to <18 years of age with a clinical diagnosis of antibiotic-resistant urinary tract infections will be recruited and randomised after informed consent is obtained via computer generated randomisation into standard of care or intervention (treatment with oral fosfomycin) arms. For children randomised into the standard of care arm: Management will be as per physician preference based on institutional prescribing practices and local antibograms. For children randomised into the intervention arm: a single dose of oral fosfomycin trometamol will be prescribed (with dosage determined based on age). Both groups will complete a tolerability questionnaire and be subject to physical examination, pathology investigations and other clinical interventions tailored to their needs as per routine standard of care. Clinical observations and results of the investigation will be recorded on a case report form via an electronic database. A follow-up safety review will be performed 10 and 28 days after enrollment.

Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard...
Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".

Storage Conditions and Breast Milk Microbiota Composition
Breast Milk CollectionMicrobial ColonizationBreast milk is the mainstay of newborn nutrition, providing all the nutrients and vitamins necessary for optimal growth of newborn infants. Beside its nutritional properties, breast milk also contains bioactive factors such as soluble immune factors, antimicrobial proteins, functional fatty acids, hormones, oligosaccharides, stem cells and microbiota. Although fresh breast milk is the optimal source of nutrition for newborn infants, breast milk must be expressed and stored in some conditions. Breast milk was thought to be sterile for many years. This idea has changed with the isolation of live bacteria in the breast milk of healthy mothers in the recent past. Thus, it has been shown that breast milk is not actually a sterile body fluid, but has a microbiota of its own. This study aimed to examine the effect of storage conditions of breast milk at different temperatures on the microbial composition of the breast milk. The prospective experimental study will be conducted under the supervision of Istanbul University, Istanbul Medical Faculty, Department of Pediatrics, Neonatology Department. Informed consent of mothers will be taken. Thirty mililiter (30 mL) breast milk that was obtained from volunteer mothers will be divided into 3 samples, each 10 mL of breast milk will be stored at different temperatures. Ten mililiter will be studied for microbial composition with 16S rRNA amplicon sequencing and bioinformatics analysis immediately, 10 mL will be stored at +4'C for 3 days and will be studied at the end of 3rd day, other 10 mL will be stored at -20'C for 3 months and will be studied at the end of 3rd months. 16S rRNA amplicon sequencing and bioinformatic analysis studies will be performed at Istanbul Medical Faculty Clinical Nutrition and Microbiota Research Laboratory. This present study is planned to be carried out for 24 months between January 2023 and December 2024

Defining COVID-19 Infection Severity on Presentation to Hospital
COVID-19Infections3 moreIn the assessment of severity in coronavirus disease 2019 (COVID-19), the modified Brit_x0002_ish Thoracic Society (mBTS),CURB65 et al. rules identifies patients with severe pneumonia but not patients who might be suitable for home management. A multicentre prospective study was conducted to derive and validate a practical severity assessment model for stratifying adults hospitalised with COVID-19 into different management groups.

Improved Respiratory Infection by Consuming Lactoferrin Fortified a2 Growing up Formula in Children...
Respiratory InfectionDiarrheal DiseaseThe goal of this observational study is to compare the incidence of ARI and/or diarrheal disease associated with feeding different formulas with and without lactoferrin supplement in children of 2-3 years old. 200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups (a2 growing up stage 3 formula puls lactoferrin supplement, and Enfinitas growing up stage 3 formula) to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data will be collected during the four visits across the study. Researchers will compare the two groups to see if there is significant decrease of the occurrence of diarrheal disease and/or acute respiratory infection for children fed with a2 growing up stage 3 formula puls lactoferrin supplement

Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex...
Anal CarcinomaHIV Infection1 moreThis clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

Melbourne Infant Study - Bacille Calmette Guérin (BCG) for Allergy & Infection Reduction
AllergyEczema1 moreTo determine if BCG immunisation at birth, compared to no BCG immunisation, leads to a reduction in measures of allergy and infection in the first 12 months of life. To evaluate the immunological mechanisms underlying the non-specific effects of BCG by comparing markers of immunity between the BCG and non-BCG groups.