Trowbridge

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are evaluating an upgraded formulation of Elemental 028 Extra, a nutritionally complete amino acid-based feed designed for patients with severe gastrointestinal tract impairments. This case study series focuses on assessing the acceptability, compliance, and gastrointestinal tolerance of the new formulation in both adult and pediatric patients who need an elemental diet due to conditions such as inflammatory bowel disease, short bowel syndrome, malabsorption, allergic diseases, and neurodegenerative disorders. Participants will receive either the powder or liquid versions of the upgraded Elemental 028 Extra feed, which contains increased energy, protein content, and micronutrients to better meet patient needs. The study includes a 1-day baseline period followed by a 28-day intervention period during which the feed is used as a sole source of nutrition. This research is conducted across multiple centers in the UK to meet regulatory requirements for acceptability studies. During the 29-day study, participants will be monitored for gastrointestinal tolerance, acceptability, compliance, and anthropometric measurements at both the start and end of the intervention. Data collection includes assessments of these outcomes to understand how well patients tolerate and adhere to the upgraded feed. The study does not include blinding and follows a protocol designed to ensure patient safety and accurate data on the nutritional supplements use.

Researchers are evaluating whether a reformulated plant-protein dominant blend in enteral tube feeds works as well as animal-protein dominant feeds in adults who receive tube feeding at home. This exploratory randomized controlled trial includes a 3-day baseline period and aims to study gastrointestinal tolerance, compliance, acceptability, body measurements, nutrient intake, and physical function over time. Participants will first continue their usual tube feeding for 3 days during the baseline. Then, for 3 months, they will receive either one or a combination of four plant-protein dominant enteral feeds or animal-protein dominant feeds control. After this intervention period, those who wish to continue will be followed for an additional 9 months, with data collected at 6 and 12 months to assess long-term outcomes. During the study, participants will be monitored for changes in gastrointestinal tolerance, acceptability, and compliance, along with measurements of body weight, height, calf circumference, and physical function tests such as the 30-second Chair Stand Test and handgrip strength. Nutritional intake and vitality measures will also be tracked from baseline through the intervention and follow-up periods. The total study participation may last up to 12 months.