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NCT ID: NCT04159259 Completed - Clinical trials for Microbial Colonization

Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)

FIB
Start date: February 13, 2019
Phase: N/A
Study type: Interventional

All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.

NCT ID: NCT04144491 Completed - Diarrhea Clinical Trials

Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

This is a nutritional trial with two arms: 1) Intervention arm of Probiotic Yoghurt containing Lactobacillus rhamnosus yoba 2012 and 2) Control arm of custard-like dairy product. The study subjects are 200 children between the age of 3-6 years that attend a school in Southwestern Uganda, Sheema district. Children will be randomized and enrolled in either the yoghurt (100 children) or the placebo (100 children) arm. The children will be monitored for 3 weeks in the baseline in regards to the incidence of common childhood diseases. During these three weeks, stool, saliva and urine samples will be collected. Also measurement of anthropometric indicators (weight and height) will take place. Subsequently, the children will consume either 100ml yoghurt or 100ml placebo product, once per day for five days per week for nine weeks, while being daily monitored in regards to the incidence of common childhood diseases. The same samples (stool, urine and saliva) and assessments (anthropometric) will take place at end line.

NCT ID: NCT04144374 Completed - Diabetes Clinical Trials

Omadacycline Tissue Penetration in Diabetic Patients With Wound Infections and Healthy Volunteers Via In Vivo Microdialysis

Start date: February 10, 2020
Phase: Phase 1
Study type: Interventional

This study will determine the tissue penetration of the novel tetracycline antibiotic, omadacycline (Nuzyra, Paratek Pharmaceuticals, Inc.), into the extracellular, interstitial fluid of soft tissue in diabetic patients with lower limb wound infections. Penetration will be compared with a group of healthy volunteer control participants.

NCT ID: NCT04123119 Completed - Diarrhoeal Disease Clinical Trials

Development of a Live Attenuated Rotavirus Vaccine as a Human Infection Challenge Model

Start date: January 22, 2019
Phase: N/A
Study type: Interventional

The impact of licensed rotavirus vaccines in LMICs is limited by their lower immunogenicity and efficacy in these settings. Improved vaccines and vaccination schedules would result in substantially greater reductions in infant diarrhoeal disease and mortality. Placebo-controlled trials of new rotavirus vaccines are no longer ethical, leading to challenges for traditional routes of licensure for vaccines that are in the development pipeline. A HIC model of rotavirus would address these challenges, whilst also offering an opportunity to study the causes of poor oral vaccine immunogenicity. Rotarix™ is in routine use in Zambia administered at 6 and 10 weeks infant age. Shedding of rotavirus vaccine after vaccination has recently been explored as a measure of mucosal immunity, analogous to oral poliovirus vaccine challenge models. We propose to explore methodological development of an attenuated vaccine as a HIC model to advance rotavirus immunology and vaccinology in Zambian infants. We will evaluate use of minimally invasive procedures including sublingual/submandibular sampling and stool collection for viral shedding as measures of vaccine-induced and naturally acquired mucosal immunity. This approach holds the potential to develop the first rotavirus HIC model in a low-income country and could be used to accelerate licensure of new rotavirus vaccines and explore causes of poor oral vaccine efficacy as well as correlates of vaccine protection. To do this, we will recruit a cohort of 22 Zambian infants receiving Rotarix™ at 6 and 10 weeks as part of their routine immunisation. Infants will be followed up actively on the day of vaccination, days 1,3,5 and 7 following each vaccine dose for collection of stool and saliva samples. Blood samples for IgA and IgG titres will be collected on days 0, 28, 31 and 56, and standard ELISA methods used to determine vaccine seroconversion. The work brings together collaborators at the Centre for Infectious Disease Research in Zambia, Imperial College in UK and Christian Medical College, Vellore in India to prepare the Zambian centre as a potential HIC model site.

NCT ID: NCT04122612 Completed - Clinical trials for Microbial Colonization

Shaping Microbiome in the First 1,000 Days of Life

AMAMI
Start date: September 23, 2018
Phase:
Study type: Observational

Events occurring in the early stages of life play an important role in the development of chronic diseases; diet and lifestyle during pregnancy are recognized to be crucial determinants in modulating offspring microbiota, throughout a vertical transfer of dysbiotic maternal ambient. Moreover, the intestinal colonization is maximized in the first two years of life through newborn's type and time of feeding. This study will provide the starting point for a future prospective observational study to assessing the association between maternal lifestyle with infant microbiota and their influence future health.

NCT ID: NCT04122495 Completed - Clinical trials for Respiratory Infection (for Example, Pneumonia, Bronchitis)

Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic

Start date: August 29, 2019
Phase: N/A
Study type: Interventional

This project aims to study the benefits of probiotics namely Bifidobacterium lactis M8 in treatment of upper and lower respiratory tract infections in young children, which are found common among children in Malaysia aged from 0-24 months.

NCT ID: NCT04120181 Completed - Infection Clinical Trials

A New Predictor Marker for Cochlear Implants Infection

Start date: May 2014
Phase:
Study type: Observational

Introduction: Surgical site infections associated with the cochlear implant can have serious consequences. Although advances in surgical techniques reduce these complications, it may be necessary to remove a device that works as a last resort as a result of ongoing infection. The removal of these devices, which are very expensive, increases the cost and takes the chance of hearing patients with this device. Therefore, it is very important to identify patients with a tendency to cochlear implant infection before surgery and to prevent these infections from occurring. Neutrophil/ lymphocyte ratio (NLR) and platelet/ lymphocyte ratio (PLR) are indicative of systemic inflammation and have a prognostic value in relation to mortality and morbidity in many diseases. The aim of this study was to identify patients with post-operative implant infection tendency in patients to be implanted with cochlear implant and to plan treatment for possible infections before cochlear implant, to reduce cost by preventing removal of implanted cochlear implant due to infection and to prevent the patient's chance of hearing through the cochlear implant from disappearing due to infection. Methods: In this retrospective study, 13 patients with cochlear implant infection were included. Preoperative NLR was calculated by dividing the neutrophil (NEU) value by the lymphocyte (LYM) value and preoperative PLR was calculated by dividing the NEU value by the LYM value.

NCT ID: NCT04117386 Completed - Pterygium Clinical Trials

Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium

Start date: January 1, 2020
Phase:
Study type: Observational

Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium

NCT ID: NCT04108637 Completed - Infection Clinical Trials

Allergy Antibiotics And Microbial Resistance

ALABAMA
Start date: July 4, 2019
Phase: N/A
Study type: Interventional

ALBAMA study is designed to find out if the effects of Penicillin allergy assessment pathway (PAAP) intervention is on penicillin prescribing

NCT ID: NCT04098900 Completed - Clinical trials for Gonococcal Infection

Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women

Start date: September 16, 2019
Phase:
Study type: Observational

This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.