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NCT ID: NCT06177184 Not yet recruiting - Clinical trials for Microbial Colonization

DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.

DO-RE-MI C-S
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born via caesarean section and require supplementation. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups. The infant gut microbiome plays a critical role in the developing immune, neurologic, and endocrine systems. Yet, most infants experience early life disruptions (ELDs) to their microbiome that have potential long-term health and development impacts. A major source of disruption is caesarean section (c-section) delivery because the infant is born surgically and is not exposed to important commensal bacteria required to establish the infant microbiome. Currently in Canada, over 28% of infants are born via c-section. Exclusive breastfeeding can improve gut microbiota composition in infants who are born via c-section. However, approximately 60% of infants born via c-section require formula supplementation in their first week of life. Evidence indicates that even one bottle of formula can further disrupt the gut microbiome. Donor human milk (DHM) is a superior alternative to formula when supplementation is required as its biotic properties minimize perturbations to the infant gut microbiome and may help to repair the microbiome in infants who experience ELDs. Yet, while DHM is well researched in preterm populations, evidence on the impact of DHM as a therapeutic intervention on the full-term infant gut microbiome is lacking. The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and higher breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.

NCT ID: NCT06176547 Not yet recruiting - H.Pylori Infection Clinical Trials

Relation of Helicobacter Pylori in Prediabetic Patients

Start date: March 1, 2024
Phase:
Study type: Observational

The primary objective of this study is to : find the relation between H.pylori infection and pre-diabetic patients with lipid profile . Specifically, the study aims to: 1. affect of H.pylori infection in pre-diabetic patients 2. realation between Pre-diabetic patient and lipid profile 3. Risk factor of H.pylori infection in pre-diabetic patients D)HbA1C test measures your average blood sugar level over the past 2 or 3 months. e)Fasting Blood Sugar Test. f) the IgG antibody of h.pylori.

NCT ID: NCT06172686 Not yet recruiting - Clinical trials for Controlled Human Malaria Infection

In-vivo Transmission Model in Semi-immune Adults

Start date: January 9, 2024
Phase: Phase 1
Study type: Interventional

Controlled human malaria infection (CHMI) has revolutionized the development of malaria vaccines. It involves the administration of either known numbers of sporozoites or infected erythrocytes to healthy human volunteers under a controlled environment. The use of highly sensitive molecular malaria diagnostic methods informs treatment decisions before symptom development and allows the characterization of parasite growth dynamics. Sporozoite CHMI has safely been used in six countries in Africa providing a platform to assess the efficacy of candidate malaria vaccines and study the natural immunity to malaria. Blood stage CHMI involves administration of known number of Artemether Lumefantrine sensitive infected erythrocytes in healthy volunteers, and it is a more sensitive model for modelling parasite growths and study the efficacy of blood-stage malaria vaccines. It has been safely used in Australia and Europe but not in Africa. Adaptation of this model by administration of combination of suboptimal and optimal antimalarial drugs lead to increased gametocytaemia, and infection rates in mosquitoes following standard membrane feeding assay. Such adaptation allows the model to be used to study parasite transmission from human to mosquitoes and evaluate transmission blocking malaria interventions. There is an urgent need to establish an in vivo model for early-stage clinical evaluation of transmission blocking interventions (TBI) in volunteers living in malaria endemic countries. This would allow rapid and cost-effective way to down-select transmission blocking candidate malaria vaccine and gametocidal antimalarial drugs before larger, more complex, and expensive field efficacy studies are conducted. A study done in naïve individual showed 100% success in establishing a malaria infection using 2800 P. falciparum infected RBCs, while a recent study (manuscript in development) has demonstrated success in establishing infection in Tanzanian semi-immune individuals with low malaria exposure using 1000 P. falciparum infected RBCs. We will use 1000 ALU-sensitive 3D7 P. falciparum infected RBCs to establish an in vivo transmission model for studying Transmission blocking interventions and assess the efficiency of two antimalarial drugs regimens (Piperaquine and doxycycline) to induce high levels of gametocytaemia and mosquito infection rates in healthy African adults. We will also investigate the determinants of successful transmission to mosquitoes including underlying immune responses to both asexual and sexual malaria antigens, asexual parasite dynamics and gametocyte burden, sex ratio of male and female gametocytes, and the relationship between gametocyte density and mosquito infection rate

NCT ID: NCT06169553 Not yet recruiting - Infections Clinical Trials

The Injection-Related InfectionS (IRIS) Program

IRIS
Start date: January 2024
Phase: N/A
Study type: Interventional

People who inject drugs are at risk of injection-related infections, like abscesses or infective endocarditis. The Injection-Related InfectionS (IRIS) program hopes to improve treatment for participants by providing a low-barrier, one-stop shop model for people who inject drugs who experience injection-related infections to access more holistic and compassionate care. IRIS is a non-randomized clinical trial, meaning that it offers a specific program to eligible patients. This program offers care for substance use and infectious disease with additional peer support and systems navigation, if interested. The investigators anticipate enrolling 80 participants in the intervention and will follow participants throughout the infection treatment period (estimated 6-12 weeks). The investigators will collect information at the time of enrolment, at the 6-month mark, and monthly via electronic medical chart review. The investigators will use an interrupted time series analysis to evaluate the impact of the intervention on rates of treatment completion, emergency department visits, hospitalizations, and death, before versus after the intervention.

NCT ID: NCT06168448 Not yet recruiting - Infectious Disease Clinical Trials

Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases

AVIEMI
Start date: December 2023
Phase:
Study type: Observational

The purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care

NCT ID: NCT06166979 Not yet recruiting - Clinical trials for Microbial Colonization

Colonisation of Scalp by Topical Probiotic Micrococcus Luteus Q24

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the skin quality improvement and colonization efficacy following the application of probiotic Micrococcus luteus Q24 (BLIS Q24) to the scalp from a serum format in healthy adults.

NCT ID: NCT06166381 Not yet recruiting - Clinical trials for Infection, Bacterial

Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries [1]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury [2]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports [3]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) [4]. Post-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis [5,6]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration [7,8]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient [9-13]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies [14,15]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment [16,17]. To date, there is no available RCT study in this field.

NCT ID: NCT06160115 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

The Role of NK Cells to Detect Blood Infection in ALL.

Start date: February 1, 2024
Phase:
Study type: Observational

1. Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry. 2. Assess the role of NK cells in development of drug resistance post chemotherapy.

NCT ID: NCT06159062 Not yet recruiting - Clinical trials for Chronic Hepatitis B Virus Infection

A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus Infection

Start date: February 27, 2024
Phase: Phase 1
Study type: Interventional

The goal of this intervention research is to learn about the safety and tolerability of 162 with a single ascending dose in subjects with chronic hepatitis B virus (HBV) infection.

NCT ID: NCT06157372 Not yet recruiting - Critical Illness Clinical Trials

Detection of Pathogen and Antibiotic Resistance Genes by Targeted Next-Generation Sequencing in ICU Patients.

Start date: December 20, 2023
Phase:
Study type: Observational

It is difficult to determine the pathogens in the early stage of infection in critically ill patients, and empirical use of broad-spectrum antibiotics for a long time is often necessary, leading to antibiotics drug resistance. Targeted next generation sequencing (tNGS) can provide faster results for pathogen and related antibiotic resistant diagnosis. But it lacks sufficient clinical evidence. Evidence regarding the clinical diagnostic accuracy and drug resistance is needed to comprehensively evaluate targeted next generation sequencing (tNGS) for diagnosis of patients in ICU who and will be critical to inform national policy.