Rotavirus

Researchers are evaluating the safety, tolerance, and side effects of brenipatide (LY3537031) in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). This Phase 2, randomized, double-blind, placebo-controlled study aims to compare brenipatide given under the skin with a placebo to assess its safety and effectiveness in treating IBS-D symptoms. The study is sponsored by Eli Lilly and Company and will last approximately 35 weeks. Participants will receive either brenipatide or a placebo via subcutaneous (under the skin) injections. The study includes two groups: one receiving the experimental drug LY3537031 and the other receiving a placebo, both administered in the same way. The treatment period and follow-up will be conducted over several weeks to evaluate the drug's impact on IBS-D symptoms. During the study, participants will record their symptoms daily using an electronic diary, focusing on abdominal pain and stool consistency. The main outcome measured is the percentage of days participants experience a significant improvement in their symptoms during weeks 9 to 16. Researchers will also monitor safety, side effects, and other symptom responses throughout the 24-week period. The study includes careful assessment of IBS-D criteria and symptom severity to evaluate treatment effects over time.

Researchers are evaluating SER-155, an experimental live bacterial therapeutic, as a first treatment option for people experiencing diarrhea due to immunotherapy-related enterocolitis (irEC). The study is a phase 1, open-label trial focused on assessing the safety and initial effectiveness of SER-155 in this group. This research is sponsored by Memorial Sloan Kettering Cancer Center and aims to find out if SER-155 causes few or mild side effects when used as a first treatment for irEC. Participants with grade 2-3 diarrhea from irEC who have not yet received immunosuppressive therapy for their condition will take SER-155 orally. This therapy consists of 16 unique bacterial strains encapsulated for oral use. The study will monitor participants over time to observe safety and preliminary efficacy, including responses and remission without the need for immunosuppressive drugs at days 15 and 43, as well as tracking the presence of SER-155 strains in stool samples. During the study, participants will be evaluated for treatment-related adverse events for up to one year. Researchers will also assess their clinical response and remission status at specific time points, monitor bacterial strain levels, and record the time to response or remission without immunosuppressive therapy. Participants will provide informed consent and comply with study protocols, including swallowing oral medication and using contraception if applicable. The total participation duration includes assessments up to one year after treatment begins.

Researchers are evaluating the use of artificial intelligence-driven virtual standardized patients (VSPs) to improve the ability of primary care doctors in China to manage common pediatric diseases. The study addresses challenges in China's pediatric healthcare system, including limited capacity in primary care and a lack of effective training tools. It involves a randomized controlled trial with over 459 doctors from various specialties across more than 10 provinces, aiming to enhance pediatric care through innovative training methods. The trial involves three groups: one using a virtual patient platform where doctors interact with AI-driven simulated patients covering diseases like pneumococcal pneumonia, rotavirus enteritis with hypovolemic shock, hand-foot-and-mouth disease, acute appendicitis, and respiratory failure; another group uses case teaching manuals, and the third group uses case teaching videos. Participants engage in a two-week learning period with their assigned training method. During the study, doctors' management skills will be assessed through clinical vignettes to measure adherence to best clinical practice guidelines. Researchers will monitor diagnosis accuracy, examination scores relevant to disease handling, and doctors' focus on patient needs. The study runs for about six months and includes over 300 primary healthcare institutions to ensure wide representation. The trial also evaluates the acceptance and costs of the training methods used.

Researchers are studying children aged 6 months to 5 years who have acute gastroenteritis, a common cause of dehydration and emergency visits. The study compares two types of intravenous fluids used for rehydration: normal saline, which has a high chloride content, and balanced crystalloids like Isolyte-S, which contain acetate and gluconate to help neutralize acid. The goal is to see if balanced fluids improve blood bicarbonate levels and other clinical outcomes compared to normal saline. The study observes children who receive either normal saline or the balanced crystalloid Isolyte-S as part of their routine care, with the treating physician deciding which fluid to use independently. No additional tests or treatments are given for research purposes. Data are collected at baseline when fluids start, about 4 hours later from routine blood tests, and 72 hours after discharge to check for return visits. During participation, children's blood tests taken as part of standard care are reviewed to evaluate changes in serum bicarbonate, blood pH, chloride levels, and other measures like time to first oral intake and hospital admission. Researchers also track if additional IV fluid boluses are needed and monitor for emergency return visits within 72 hours. The study lasts through these observation points without extra procedures beyond usual care.

Researchers are evaluating the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI) to reduce cholera infections and promote lasting WASH behaviors in areas near cholera cases in Bangladesh. Cholera causes millions of infections globally each year, and this study focuses on people living close to cholera patients who are at much higher risk during the first week after the patient receives care. The study aims to find scalable ways to deliver effective WASH interventions to these high-risk communities. The study involves three phases: development and planning of the intervention using interviews and pilot testing, implementation and evaluation through a randomized controlled trial, and dissemination of findings for policy planning. Participants in the trial will be divided into two groups. One group receives the usual advice on oral rehydration and a WASH leaflet during a single visit. The other group participates in group sessions led by a health promoter who teaches about diarrhea spread, handwashing, water treatment, and safe water storage. These households also receive a cholera prevention package and weekly voice and text messages for 12 months promoting WASH behaviors. Water and clinical samples will be analyzed to study cholera transmission. Participants will be followed for one month to track new cholera infections and for 12 months to observe diarrhea cases and WASH behaviors. Data collected includes handwashing frequency, water quality, psychosocial factors, and child growth assessments. The study measures the number of cholera infections in the participant rings around cholera cases as the primary outcome. Safety monitoring and long-term follow-up are integrated throughout the trial, which is expected to provide important evidence on controlling cholera through targeted WASH interventions.

Access to safe drinking water remains a major challenge in rural households of developing countries, leading to millions of deaths annually due to unsafe water sources. This research evaluates a program that provides coupons for free dilute chlorine solution to improve child health by reducing diarrhea, fever, and cough incidents. The study is a large-scale randomized controlled trial conducted at health clinics, assessing the sustained health impacts and behavior related to chlorine use and health clinic visits. Participants are randomly assigned to receive coupons redeemable for a monthly supply of a 150ml bottle of dilute chlorine solution at registered health facilities for 12 months or to a control group that receives no coupons after enrollment. The intervention is delivered via SMS with an ID for coupon redemption after enrollment over a phone call. The study is conducted in collaboration with the Kenya Medical Research Institute at Health and Demographic Surveillance Systems sites. Participants are monitored for chlorine use in drinking water at 6-month intervals up to 36 months, along with assessments of child illness occurrences like diarrhea and fever. Data collection also includes child mortality and verbal autopsies for deceased children, providing valuable information for future studies on the mortality impact of chlorine distribution. The study involves ongoing data collection on self-reported health facility visits and objective measures of chlorine use over the study period.

Researchers are conducting a prospective observational study to understand ileorectal syndrome, which may develop in patients who have had total colectomy and ileorectal anastomosis. The study aims to evaluate how often this syndrome occurs, how severe the symptoms are, and how it impacts patients' quality of life. It also seeks to explore the relationship between bowel dysfunction after surgery and quality of life, as well as clinical factors that influence symptom severity. Participants will be observed over a 12-month period, starting from the baseline and continuing to one year. This study involves collecting data through questionnaires focused on postoperative bowel function and symptoms. The study does not involve any invasive procedures or treatments, and data such as demographic information, surgical details, and laboratory results will also be collected for analysis. During the study, participants will complete surveys and follow-up assessments regarding their bowel symptoms and quality of life. The research team will monitor symptom severity and bowel function over time, using patient-reported outcomes. The study is designed to increase awareness and improve management strategies for ileorectal syndrome without adding medical risks, with all data gathered by the responsible investigator at the clinic.

Researchers are evaluating the effectiveness and safety of fecal microbiota transplantation (FMT) for patients with irritable bowel syndrome (IBS) who have high proteolytic activity. This study focuses on using stool from donors with low proteolytic activity containing the bacteria Alistipes putredinis. Proteolytic activity refers to the breakdown of proteins into smaller components, and the trial aims to see if this approach can impact IBS symptoms. This is a phase 2 randomized, double-blind study. Participants will receive a single FMT using 50 grams of freeze-thawed stool either from a donor with low proteolytic activity (experimental group) or from their own stool (placebo comparator group). The treatment is administered via colonoscopy, and only one transplantation is given. The study compares donor stool transplantation to autologous transplantation to assess differences in outcomes. During the 12-week study period, participants will be monitored for responses to treatment, including changes in fecal proteolytic activity and symptom relief using questionnaires. Assessments include measuring the proportion of the bacteria Alistipes putredinis post-FMT and lactulose excretion levels. Safety is also monitored, and the primary outcome is the percentage of responders at 12 weeks. The trial involves women aged 18 to 70 with moderate to severe IBS symptoms, with follow-up evaluations at baseline and 12 weeks.

Researchers are evaluating how well fecal microbiota transplantation (FMT) works to treat diarrhea or colitis caused by immune-checkpoint inhibitors in patients with genitourinary and other cancers. This Phase 1 trial aims to assess the safety and effectiveness of FMT in achieving remission or clinical response of immune-related diarrhea or colitis, along with monitoring recurrence rates and changes in immune and microbiome markers. Participants first receive loperamide by mouth, followed by FMT administered via colonoscopy 4 hours later over 15-30 minutes. After treatment, patients are monitored closely with follow-up visits at 2, 4, and 8 weeks, and again at 3 months. The trial also evaluates PuraStat gel for healing mucosal ulcers and controlling bleeding if needed. During the study, participants will undergo assessments to track side effects related to FMT and measure clinical response or remission of diarrhea and colitis symptoms. Researchers collect tissue, blood, and stool samples to study immunological and microbiome changes. Safety monitoring continues up to 3 months post-treatment to observe recurrence and long-term effects, with a total participation duration of about 3 months.

Researchers are conducting a phase 1 clinical trial to study the safety and immune response of a new vaccine called IVT Shigella-04 in healthy young adults aged 18 to 49 years. This study compares five different dose levels of the vaccine, given with or without an adjuvant, to a placebo. The goal is to evaluate how well the vaccine stimulates the immune system and to monitor any side effects. Participants will be randomly assigned to one of six groups to receive two intramuscular injections of either the IVT Shigella-04 vaccine at varying doses or a placebo (saline) 28 days apart. The vaccine formulations include low, medium, and high doses, some combined with an adjuvant to potentially enhance the immune response. The study is double-blind, meaning neither participants nor researchers know who receives the vaccine or placebo. During the trial, participants will attend scheduled visits for health assessments, blood tests, and monitoring of any reactions for up to six months after the second dose. Researchers will track immediate vaccine reactions, adverse events, and immune responses by measuring specific antibodies against Shigella. The total study duration for each participant includes screening, vaccination, and follow-up to ensure safety and gather detailed immune data.