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In this study we will enroll healthy pre-menopausal female volunteers in the community. The subjects will act as their own controls. The subjects will collect voided urine and peri-urethral swab specimens daily for several months. They will also be asked to collect vaginal and peri-rectal swab specimens at various time points. Subjects will document various lifestyle variables daily. During the middle of the study, subjects will be randomized to probiotic vs placebo. Using bacterial culture and 16S rRNA gene sequencing, we will measure the bacterial populations of several anatomic sites longitudinally: voided urine, peri-urethra, vagina, and peri-rectal. We hypothesize that oral probiotic usage will alter the bacterial populations and ratio of Lactobacillus to E. coli within each of these sites. Additionally, we hypothesize that the changes within each site will occur first in the rectum (i.e. GI tract), followed by the vagina, and then the urethra and bladder. Using the prospective design of daily sampling and lifestyle variable documentation, we will additionally be able to identify possible influencers on microbiome stability within the sampled sites. The lifestyle variables recorded include: diet, medication usage, menstruation, sexual activity, and alcohol consumption. This pilot study will establish the variance of our outcome variable among women and confirm the emergence of the probiotic with the recommended dose. With this information, we will be able to calculate the power needed for a larger randomized trial. This trial would also randomize patients who are at risk for UTI to receiving probiotic vs placebo. The primary outcome measurement will be the change in the ratio of Lactobacillus to E. coli. As s secondary aim we will evaluate the incidence of UTI in the patients.
The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.
The purpose of this study is to see if a new brain stimulation technique, static magnetic field stimulation (tSMS), which involves holding a static neodymium magnet over the scalp, can influence normal rhythms of brain activity.
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of food on bioavailability.
This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203.
The primary aim of this investigation is to assess the safety, feasibility and performance of the VIPUN Balloon Catheter 0.1 in the assessment of gastric motility. The investigation will also assess whether the inflation of the VIPUN Balloon Catheter can stimulate gastric motility and emptying. Furthermore, this investigation will examine whether gastric motility and emptying as measured in this study are correlated.
This study is a phase 1 study of PF-06700841. PF-06700841 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06700841 after multiple oral doses of PF-06700841 in Japanese healthy volunteers.
People who eat diets low in choline (LC) should deplete their choline (Cho) stores, and measurements of Cho pool size using isotope dilution should reflect this depletion. Investigators will identify a biomarker panel that correlates well with measured Cho pool size across the range of different degrees of depletion.The investigators propose that, as body stores of Cho diminish, cells and organs will reach the point when metabolism/function in the cell is altered, and that this will result in a progression of changes in biomarkers that reflect Cho status.
This study is a phase 1 study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 after multiple oral doses of PF-06651600 in Japanese healthy volunteers.
Part 1 (SRD (Single-rising dose)): The primary objective of this trial part is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after single dosing. Part 2 (MRD (Multiple-rising dose)): In Part 2, the primary objective is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics of BI 1015550 after multiple dosing.