Author Interviews, Diabetes, Ophthalmology / 20.05.2019

MedicalResearch.com Interview with: Thulasiraj Ravilla Executive Director – LAICO & Director – Opeations Aravind Eye Care System Tamilnadu, India  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Diabetic Retinopathy (DR) is a visual consequence of diabetes and various other studies have reported that in India, 10% to 30% of adults with diabetes have DR, with higher rates found in older people and urban areas. Undetected DR leads to vision loss and eventually blindness. Thus early identification of DR is critical to initiate appropriate treatment to reduce the rate of vision loss. Conventional approaches of requesting diabetologists to refer patients with diabetes to an ophthalmologist has been ineffective due to compliance issues, both by the diabetologists and the patients. Similarly screening through outreach eye camps have not been found to be effective in India and other developing countries owing to inadequate eye care resources. Teleretinal screening for Diabetic Retinopathy is increasingly being used in India. Evidence from randomized clinical trials on the benefits of teleretinal screening is limited. Whatever evidence is there are from high income countries, which often have little relevance to developing countries. (more…)
Author Interviews, Psychological Science, Sexual Health / 19.05.2019

MedicalResearch.com Interview with: Prof. Leif Edward Ottesen KennairDepartment of PsychologyFaculty of Social and Educational SciencesNorwegian University of Science and TechnologyProf. Leif Edward Ottesen Kennair Department of Psychology Faculty of Social and Educational Sciences Norwegian University of Science and Technology MedicalResearch.com: What is the background for this study?   Response: Previous studies on intercourse frequency mainly focused on individual data, with no possibility to verify the perceived initiative or frequency. Couples data gave us that possibility. Previous studies had also mainly treated relationship quality as one measure. Therefore it was also interesting to distinguish between various aspects of relationship qualities to try to disentangle how these different aspects were related to frequency of intercourse. In addition we had some ideas about how a measure of sexual personality or sociosexuality—how interested in short-term sex one is—might be relevant for compromise within the relationship? (more…)
Author Interviews, Emory, Heart Disease, JAMA, Pediatrics, Sugar / 19.05.2019

MedicalResearch.com Interview with: Jean A. Welsh, RN, MPH, PhD Departments of Epidemiology and Pediatrics Emory University Wellness Department, Children’s Healthcare of Atlanta Atlanta, Georgia MedicalResearch.com: What is the background for this study? Response: As the evidence has accumulated regarding the health risks associated with sugar-sweetened beverages, I’ve wondered about fruit juices.  Though they have a kind of healthy halo, their main ingredients are the same as sugar-sweetened beverages, sugar and water.  We know that young children drink a lot of fruit juice, and I’ve wondered if older children and adults might switch to drinking more as concern grows about soft drinks and other sugar-sweetened beverages. (more…)
Author Interviews, Pediatrics, Smoking, Tobacco, Tobacco Research / 19.05.2019

MedicalResearch.com Interview with: Bonnie Halpern-Felsher, PhD, FSAHM Dr. Halpern-Felsher Professor of Pediatrics Director of Fellowship Research Department of Pediatrics Director of Research, Division of Adolescent Medicine Associate Director, Adolescent Medicine Fellowship Program Co-leader, Scholarly Concentrations, Pediatrics Residency Program Stanford University Hoda S. Abdel Magid, MHS, PhDPostdoctoral ScholarDepartment of Health Research & PolicyStanford UniversityHoda S. Abdel Magid, MHS, PhD Postdoctoral Scholar Department of Health Research & Policy Stanford University MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Dr. Hoda Magid, my former graduate student, and I wanted to examine whether owning promotional items for e-cigarettes and other non-cigarette products predicted youth use of those products.  Other studies have examined whether ownership of coupons, samples, and other promotional materials influenced cigarette use, but no longitudinal study examined other tobacco products. Our findings show that non-tobacco using youth who own items to promote e-cigarettes and other alternative tobacco products are twice as likely to use alternative tobacco products a year later. (more…)
Author Interviews, Dermatology, Science, Surgical Research, Technology / 19.05.2019

MedicalResearch.com Interview with: Haishan Zeng, PhDDistinguished ScientistImaging Unit - Integrative Oncology DepartmentBC Cancer Research CentreProfessor of Dermatology, Pathology, and Physics, University of British ColumbiaVancouver, BC, Canada Haishan Zeng, PhD Distinguished Scientist Imaging Unit - Integrative Oncology Department BC Cancer Research Centre Professor of Dermatology, Pathology, and Physics, University of British Columbia Vancouver, BC, Canada  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We developed a fast multiphoton microscope system that enables clinical imaging of the skin at the level of cellular resolution. With this system, we can see microstructures inside of the skin without cutting into it. We subsequently conceived the idea of directly treating the microstructures that are responsible for disease. We increased the laser power to generate intense localized heat to destroy the targeted structure. In this study, we demonstrated the feasibility of this new treatment by targeting and closing single blood vessels using our new microscope.  (more…)
Author Interviews, Cancer Research, Cost of Health Care, JAMA / 19.05.2019

MedicalResearch.com Interview with: Nina Niu Sanford, M.D.  Assistant Professor UT Southwestern Department of Radiation Oncology Dallas TX 75390  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background for this study is that we know cancer survivors are at risk for uninsurance or underinsurance and the most commonly cited reason for this is cost of insurance.  However, there have been no prior studies assessing from the patient perspective the reasons for not having insurance. In addition, there has been further recent controversy over the Affordable Care Act, including threats from the current administration to dismantle it.  Thus assessing the impact of the ACA among at risk populations including cancer survivors is timely. (more…)
Author Interviews, Genetic Research / 17.05.2019

MedicalResearch.com Interview with: Tove Fall PhD Senior author of the study Associate Professor in Epidemiology Department of Medical Sciences and the Science for Life Laboratory Uppsala University  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Dog ownership is common in the Western society but little is known about what actually makes people get a dog. We conducted a twin study to understand whether the genetic make-up has an influence on this choice. We found that more than 50% of the differences in dog ownership is explained by genetic variants.  (more…)
Author Interviews, Diabetes, Ophthalmology, Regeneron / 17.05.2019

MedicalResearch.com Interview with: Robert L. Vitti, MD, MBA Vice President and Head, Ophthalmology Regeneron Pharmaceuticals Dr. Vitti discusses the recent announcement that the FDA has approved EYLEA to treat all stages of diabetic retinopathy. MedicalResearch.com: Can you provide additional background on this approval? Would you briefly explain diabetic retinopathy and it's impact on patients? Response: The FDA has approved EYLEA (aflibercept) Injection to treat all stages of diabetic retinopathy (DR). DR is the leading cause of blindness among working-aged American adults. Approximately 8 million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina (per 2010 data). The disease generally starts as non-proliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. Over time, NPDR often progresses to proliferative diabetic retinopathy (PDR), a stage in which abnormal blood vessels grow on the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. (more…)
Author Interviews, CDC, OBGYNE, Race/Ethnic Diversity / 17.05.2019

MedicalResearch.com Interview with: Emily Petersen, MD. Lead for the Pregnancy Mortality Surveillance System Division of Reproductive Health   MedicalResearch.com: What is the background for this study? Response: About 700 women die of pregnancy-related causes each year in the United States. The new analysis provides much-needed perspective on the circumstances surrounding pregnancy-related deaths and summarizes potential strategies to prevent future deaths. (more…)
Accidents & Violence, Author Interviews, Diabetes, Neurology / 17.05.2019

MedicalResearch.com Interview with: foot-neuropathyMonica Perazzolo Research Centre for Musculoskeletal Science and Sports Medicine School of Healthcare Science, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK Department of Biomedical and Neuromotor Sciences University of Bologna, Bologna, Italy  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our research on motor control in diabetes focussed on the effect of diabetic peripheral neuropathy on driving. Drivers with diabetic peripheral neuropathy showed a less well controlled use of the accelerator pedal and sometimes larger, faster steering corrections needed to stay in lane when driving a simulator compared to healthy drivers and people with diabetes but no neuropathy. Despite these negative findings, an important result is that drivers with diabetic peripheral neuropathy demonstrated an improvement in their driving with practice.  (more…)
Author Interviews, Education, Neurology, NYU / 17.05.2019

MedicalResearch.com Interview with: Dr. Rebecca Stainman Dr. Arielle Kurzweil MD Adult Neurology Program Director New York University School of Medicine NYU Langone Health MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Physician burnout is prevalent. Neurologists have among the highest burnout rates, ranked third among specialties in a 2011 study, and over half of US Neurologists report at least 1 symptom of burnout in a 2016 survey.  Efforts to address burnout in training programs have mostly been aimed at implementing wellness curricula and offering mental health resources. Training neurology residents to effectively identify, address, and help impaired colleagues is equally crucial in these efforts, yet there is a paucity of literature on this topic. We used simulation as a means of addressing this topic, via identifying and addressing an impaired colleague through an objective structured clinical examination (OSCE).  (more…)
Author Interviews, Brigham & Women's - Harvard, Opiods, Orthopedics, Pain Research, Surgical Research / 16.05.2019

MedicalResearch.com Interview with: Marilyn M. Heng, MD, MPH, FRCSC Orthopaedic Trauma Surgeon Assistant Professor of Orthopaedic Surgery Harvard Medical School  MedicalResearch.com: What is the background for this study?   Response: The ultimate background for this study does come from the larger context of the opioid epidemic that is seen worldwide but particularly in North America. Orthopaedic surgeons should take responsibility as being among the top prescribers of opioids. The more specific background that led to this specific study was the observation that several colleagues would insist that a drug like hydromorphone was so dangerous that they would not prescribe it but seemed okay prescribing large amounts of oxycodone.  It seemed like an urban myth that the type of opioid was what made it dangerous, so that led us to do the study to see if there was evidence for that.  (more…)
Author Interviews, Exercise - Fitness, Lifestyle & Health, Weight Research / 16.05.2019

MedicalResearch.com Interview with: sneakers-walkingFrancesco Zaccardi, MD, PhD Clinical Epidemiologist Assistant Director Leicester Real World Evidence Unit Leicester Diabetes Centre UK MedicalResearch.com: What is the background for this study? Response: The role of excess body weight on mortality has been extensively investigated during the last decades. Studies from several countries have also shown, however, that the risk of death in persons who are overweight or obese is lower if their fitness, a parameter indicating cardio-pulmonary health, is higher. Most of these studies reported the beneficial effect of fitness in terms of relative risk reduction, for example 20% reduction of risk of death. Relative estimates, though, are difficult to interpret. (more…)
Addiction, Author Interviews, Coffee / 16.05.2019

MedicalResearch.com Interview with: Dr Lorenzo Stafford, PhD, CPsychol Senior Lecturer, Department of Psychology University of Portsmouth Portsmouth  MedicalResearch.com: What is the background for this study?   Response: The background to this work was that I had been thinking for sometime on the role of our sense of smell in drug consumption and addiction.  Most of the research in this area is dominated by visual processes, in particular showing how cues associated to drugs (e.g. packet of cigarettes, bottle of beer) become conditioned in such drug users. That work has been useful in explaining how in recovering addicts, long after the withdrawal symptoms have subsided, when exposed to such cues, they can nevertheless relapse to craving and consuming the drug; hence though a powerful driver, addiction is not just about reversing withdrawal symptoms. However, most of our richer experiences are multisensory, so it seems likely that other senses must also play a role in the addictive process. Years ago, I completed a PhD on the topic of caffeine and with the general importance placed on the sensory (especially smell) aspects of coffee, all planted the seed for a possible study. We completed two experiments that examined the lowest concentration at which participants (high, moderate and non-coffee consumers) could detect (Threshold test) a coffee associated chemical (exp 1) and in a separate task, how fast they were at identifying (Recognition test) the odour of real coffee. In experiment 2, participants (coffee consumers and non-consumers) completed the same Threshold test for the coffee odour but also completed a Threshold test for a control odour. (more…)
Author Interviews, Gender Differences, Psychological Science / 15.05.2019

MedicalResearch.com Interview with: Prof. Wai-Man (Raymond) Liu, PhDAssociate ProfessorResearch School of Finance, Actuarial Studies & StatisticsCollege of Business & Economics BuildingThe Australian National UniversityProf. Wai-Man (Raymond) Liu, PhD Associate Professor Research School of Finance, Actuarial Studies & Statistics College of Business & Economics Building The Australian National University MedicalResearch.com: What is the background for this study? Response: In our study, we studied survey responses of over 26,000 people from the largest Australian household survey over a period of 14 years. The survey was funded by the government called “The Household, Income and Labour Dynamics in Australia (HILDA) Survey”. The survey was conducted by the Melbourne Institute. In the survey more than 9,500 of these respondents had experienced the death of a close friend. (more…)
Aging, Author Interviews, Fertility, OBGYNE / 15.05.2019

MedicalResearch.com Interview with: Nancy Phillips, MD Clinical Assistant Professor Rutgers Robert Wood Johnson Medical School Women's Health Institute New Brunswick, NJ MedicalResearch.com: What is the background for this study? What are the main findings? Response: The background of this article was as an interest piece prompting a literature review. We both felt it represented an underserved clinical need. The main findings are that the paternal age at conception does impact pregnancy outcomes,  including pregnancy complications, fetal chromosomal anomalies and childhood cancers and psychological disorders. (more…)
Author Interviews, Brigham & Women's - Harvard, JAMA, Orthopedics, Osteoporosis, Surgical Research / 15.05.2019

MedicalResearch.com Interview with: Elaine W. Yu, MD, MMSc Assistant Professor,  Harvard Medical School Director, Bone Density Center Endocrine Unit, Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Roux-en-Y gastric bypass (RYGB) is a popular surgical weight loss procedure.  We have previously shown that gastric bypass leads to rapid high-turnover bone loss. Bariatric procedures are being increasingly performed in older adults, and the clinical consequences of gastric bypass-associated skeletal changes in this vulnerable population have been unclear to date.  Thus, we used Medicare claims data to investigate fracture risk among older adults after gastric bypass, and in comparison to adults who received another bariatric procedure called adjustable gastric banding (AGB), which is thought to have fewer negative bone effects. In our analysis, we found that patients undergoing Roux-en-Y gastric bypass were 73% more likely to fracture than those undergoing AGB. Importantly, we found that hip fracture risk increased nearly 180% after RYGB, and that fracture rates in patients aged 65 or older were similar to the overall group.  (more…)
Annals Internal Medicine, Author Interviews, Critical Care - Intensive Care - ICUs, Infections, University of Pittsburgh / 15.05.2019

MedicalResearch.com Interview with: Minh-Hong Nguyen, MD Infectious Diseases Professor of Medicine Director, Transplant Infectious Diseases Director, Antimicrobial Management Program Department of Medicine University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Blood cultures, the gold standard for diagnosing blood stream infections, are insensitive and limited by prolonged time to results. Early institution of appropriate antibiotics is a crucial determinant of improved outcomes in patients with sepsis and blood stream infections (BSI). For these reasons, development of rapid non-culture diagnostic tests for blood stream infections is a top priority. The T2Bacteria panel is the first direct from blood, non-culture test cleared by FDA for diagnosis of blood stream infections .  It detects within 4-6 hours the 5 most common ESKAPE bacteria that are frequent causes of hospital infection, and which are often multi-drug resistant.  This study shows that the T2Bacteria panel rapidly and accurately diagnosed and identified ESKAPE bacterial BSIs, and identified probable and possible BSIs that were missed by blood cultures (in particular among patients who were already receiving antibiotics). (more…)
Author Interviews, Heart Disease, Pharmacology / 14.05.2019

MedicalResearch.com Interview with: Sami Viskin MD Tel-Aviv Medical Cente Sackler School of Medicine Tel-Aviv University, Israel. MedicalResearch.com: What is the background for this study? What are the main findings?  Response: There are >200 medications with reported QT-prolonging risk. The majority of these medications do not even have cardiac indications, yet cause unintended QT-prolongation because they block IKr potassium channels in myocardial cells. With so many drugs, of such varied composition, blocking the IKr channel, it is reasonable to assume that food compounds also have IKr-channel-blocker properties, raising the possibility that proarrhythmic food exists. We tested the effects of grapefruit on the QT interval with the rigorous methodology used by the pharmaceutical industry to test new medications before they are released to the market. (more…)
Author Interviews, Cost of Health Care, Kidney Disease, UCLA / 14.05.2019

MedicalResearch.com Interview with: Chris Childers, MD, PhD Division of General Surgery David Geffen School of Medicine at UCLA Los Angeles, CA 90095 MedicalResearch.com: What is the background for this study? Response: Patients with end-stage renal disease – poorly functioning kidneys – often have to receive dialysis. This typically requires a patient to visit an outpatient clinic several times a week to have their blood filtered by a machine. Over the past few years, two for-profit companies have increased their control over the outpatient dialysis market – DaVita and Fresenius. Combined they control approximately ¾ of the market.  A number of concerns have been raised against these for-profit companies suggesting that the quality of care they deliver may be worse than the care delivered at not-for-profit companies. But, because they control so much of the market and because patients have to receive dialysis so frequently, patients may not have much choice in the clinic they visit. Medicare covers patients who are 65 years or older and also patients on dialysis regardless of age.  Medicare pays a fixed rate for dialysis which they believe is adequate to cover the clinics' costs. However, if a patient also has private insurance, the insurer is required to pay for dialysis instead of Medicare. Whereas Medicare rates are fixed by the federal government, private insurers have to negotiate the price they pay, and may pay much more as a result. (more…)
Author Interviews, Cancer Research, HPV, Urology / 13.05.2019

MedicalResearch.com Interview with: Lael S. Reinstatler, MD, MPH. PGY 4 Urology Residency Dartmouth Hitchcock MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Human Papillomavirus is an oncogenic virus associated with other genitourinary cancers including penile cancer. HPV is detectable in urine and in urethral swabs and it interacts with stratified squamous epithelium which lines the majority of the genitourinary tract. Prior research has identified HPV in bladder tumors but detection methods are inconsistent. In this study, we looked for an association with HPV serology (indicating prior HPV systemic exposure) and bladder cancer. (more…)
Author Interviews, Medical Imaging, Mental Health Research, UCSD / 13.05.2019

MedicalResearch.com Interview with: Dr. Mingxiong Huang, PhD Professor, Electrical and Computer Engineering University of California, San Diego MedicalResearch.com: What is the background for this study?   Response: Combat-related mild traumatic brain injury (mTBI) is a leading cause of sustained impairments in military service members and Veterans. Yet, conventional neuroimaging techniques such as magnetic resonance imaging (MRI) and computed tomography (CT) are typically insensitive to physiological alterations caused by mild and some moderate TBIs. With funding from the VA, we have pursued in developing sensitive imaging markers based on magnetoencephalography (MEG) for mTBI. This paper reflects the news MEG findings in this research field.  (more…)
Author Interviews, Hip Fractures, JAMA, Supplements / 13.05.2019

MedicalResearch.com Interview with: Prof. Haakon E Meyer, PhD Department of Public Health and Global Health Norwegian Institute of Public Health Oslo, Norway MedicalResearch.com: What is the background for this study? What are the main findings? Response: The use of high dose vitamin supplementation is popular in parts of the population, often without any clear indication and in the absence of clear evidence of benefit. However, side effects can occur, and in a previous published secondary analysis of double blinded randomized controlled trials, we found to our surprise an increased risk of hip fracture in those supplemented with high doses of vitamin B6 in combination with vitamin B12. This finding was re-assessed in the current study employing data from the large observational Nurses' Health Study. As in the previous study, we found that a combined high intake of vitamin B6 and B12 was associated with increased risk of hip fracture. (more…)
Author Interviews, Biomarkers, Cancer Research, Colon Cancer, JAMA, Karolinski Institute / 13.05.2019

MedicalResearch.com Interview with: Louise Olsson MD PhD Senior researcher Department of Molecular Medicine and Surgery Colorectal Surgery Karolinski Institute Stockholm, Sweden  MedicalResearch.com: What is the background for this study? What are the main findings? Response: I read a very interesting paper back in 2006 “Detection and quantification of mutation in the plasma of patients with colorectal cancer”. Only some 60 % of patients with early colorectal cancer were detectable in this way whereas patients with stage IV disease all had a high concentration of APC mutations in their plasma. So the prospects of using the method for example, screening of primary colorectal cancer seemed limited but I thought wow, this is the test to detect recurrences and generalized disease during follow-up after surgery for colorectal cancer. After some discussion we started to collect plasma samples from patients at the hospital where I worked and that´s how my research began. (more…)
Author Interviews, Coffee, Heart Disease, Nutrition / 13.05.2019

MedicalResearch.com Interview with: Professor Elina Hypponen Professor in Nutritional and Genetic Epidemiology Director: Australian Centre for Precision Health  Australian Centre for Precision Health| University of South Australia Cancer Research Institute | South Australian Health & Medical Research Institute  MedicalResearch.com: What is the background for this study? Response: In Randomised controlled trials caffeine, which is a key constituent of coffee, has been shown to increase blood pressure. There is also some past evidence to suggest that higher coffee consumption may increase the risk of cardiovascular disease, but only in individuals who are slow caffeine metabolisers. We used information from about 350,000 individuals from the UK, to look at the association between patterns of  habitual of coffee consumption and the subsequent risk of cardiovascular disease. As we also know that people are genetically different with respect to their ability to metabolise caffeine, a further aim for our study was to look at whether those people who are able to metabolise caffeine effectively, may also be more resistant to possible cardiovascular effects of coffee, compared to those who metabolise caffeine more slowly.  (more…)
Author Interviews, Brain Injury, Neurological Disorders, Neurology, Stroke / 12.05.2019

MedicalResearch.com Interview with: Thomas M Van Vleet PhD Posit Science  Dr. Tom Van Vleet,  presented results on a common symptom of stroke and acquired brain injury (hemi-spatial neglect) at the American Academy of Neurology May 2019 MedicalResearch.com: What makes this study newsworthy? Response For the first time ever a highly-scalable intervention — computerized brain training (BrainHQ made by Posit Science) —was found to improve symptoms of hemi-spatial neglect, which is a common and often intractable and debilitating problem after stroke or other acquired brain injury. MedicalResearch.com: What can you tell us about the medical condition (hemi-spatial neglect) investigated in this study? Response About a third of patients with a brain injury exhibit a complex and debilitating array of neurological deficits known as the “neglect syndrome” (sometimes called, “hemi-spatial neglect” or “neglect”). The most apparent symptom of neglect is the inability of patients to efficiently process information on the side of space opposite the injury; often completely missing relevant events without awareness. As a result, patients often fail to adopt compensatory strategies or respond to other conventional rehabilitation protocols. The cost is significant, as patients with neglect experience longer hospital stays and have higher requirements for assistance, including greater skilled nursing home placements relative to patients with similar extent of brain injury without neglect. To date, there’s been no broadly-applicable and highly-scalable intervention for addressing neglect. An alarming reality given the increasing cost of stroke, which is currently estimated to exceed $34 billion per annum (more…)
Author Interviews, JAMA, Opiods, Primary Care, University of Michigan / 11.05.2019

MedicalResearch.com Interview with: Kao-Ping Chua, M.D., Ph.D. Department of Pediatrics Susan B. Meister Child Health Evaluation and Research Center University of Michigan, Ann Arbor MedicalResearch.com: What is the background for this study?   Response: Doctor and pharmacy shopping is a high-risk behavior in which patients obtain opioid prescriptions from multiple prescribers and fill them at multiple pharmacies. Because this behavior is associated with a high risk of overdose death, there have been many efforts to help clinicians detect doctor and pharmacy shopping among patients prescribed opioids. For example, 49 states have a prescription drug monitoring program that provides information on patients’ prior controlled substance prescriptions. In contrast, there has been little attention to the possibility that patients prescribed opioids may have family members who are engaged in opioid doctor and pharmacy shopping. Such family members may divert opioids prescribed to patients because of their access to these opioids. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, Johns Hopkins, Lipids / 09.05.2019

MedicalResearch.com Interview with: Rajesh Kumar NV, Ph.D. Affiliation during the study: Senior Manager, Human Therapeutics Division, Intrexon Corporation, Germantown, MD, USA Current affiliation: Translational Research Program Manager, Oncology Drug Discovery, Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine Baltimore, MD,   MedicalResearch.com: What is the background for this study? Response: Clostridium difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Clostridium difficile infection is the most frequent form of colitis in hospitals and nursing homes and affects millions of patients in the United States and abroad. Clostridium difficile associated disease (CDAD) is a global public health challenge where even mild to moderate infections at times can quickly progress to a fatal disease if not treated promptly. OG253 is a novel lantibiotic in development for the treatment of CDAD. Lantibiotics are antimicrobial peptides whose chemical structure includes a bridge maintained by the non-canonical amino acid lanthionine. The primary objective of our study was to evaluate the repeated dose toxicokinetics and any possible side effects of OG253 as enteric-coated capsules following daily oral administrations of three different doses (6.75, 27 and 108 mg/day) for a single day or seven consecutive days in both genders of rats. An enteric-coated capsule of OG253 was formulated in an attempt to circumvent the proteolytic degradation of OG253 in the upper digestive tract and specifically deliver this lantibiotic to the distal portion of the small intestine. (more…)