Travel-related Illness

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics single and multiple intravenous doses of a drug called BWC0977 in healthy adult volunteers. This Phase 1 study involves a total of 64 healthy adults aged 18 to 55 years and is designed as a randomized, double-blind, placebo-controlled trial with multiple dose groups. The study focuses on measuring any treatment-emergent adverse events and serious adverse events to understand the drugs safety profile. Participants will be divided into two main groups single ascending dose SAD and multiple ascending dose MAD cohorts. In the SAD phase, volunteers receive one intravenous infusion of BWC0977 or placebo over 2 hours at doses of 750 mg or 1500 mg. In the MAD phase, participants receive multiple intravenous infusions of BWC0977 or placebo over 30 minutes to 2 hours daily for 7 to 10 consecutive days. Dose levels will increase sequentially based on safety and tolerability data collected during the study. During the study, participants will undergo various assessments including physical exams, vital signs, ECGs, laboratory tests, and blood sampling at specific times before, during, and after infusions to monitor safety and measure drug levels in the body. Researchers will track adverse events for up to 8 days after single dosing and up to 16 days after multiple dosing. Volunteers must comply with study visits and requirements throughout the trial, which lasts until August 2026.

Researchers are evaluating a new strategy to improve the rapid and accurate identification of febrile children aged 2 to under 5 years at risk of life-threatening infections in sub-Saharan Africa. The study compares the current standard of care using IMCI-based guidelines to a new method that adds a rapid point-of-care test measuring suPAR biomarker levels. The goal is to see if this combined approach leads to better decisions about hospital admission, referral, or discharge, and ultimately improves health outcomes. The trial involves two groups one receiving standard IMCI-based care and the other receiving IMCI-based care enhanced by suPAR testing. Blood samples will be taken from all children, but only those in the suPAR group will have their suPAR levels measured on-site using a special device. Decisions about admitting or discharging children during the first clinical assessment will be guided by these results, especially for those with higher suPAR levels indicating greater risk. A second clinical assessment by an independent physician will help ensure safety and confirm decisions. Participants will be monitored with follow-up visits on days 3 and 7 after enrollment, plus additional check-ins if their condition worsens. A 28-day follow-up interview will track serious events, hospitalizations, or deaths, with an optional 3-month follow-up for further health status updates. Throughout the study, children will receive routine treatments as needed. Researchers will measure the appropriateness of discharge decisions, hospital referrals, survival, symptom duration, and other health outcomes to assess the new triage method.

Researchers are studying the safety and immune response of the CHIKV VLP vaccine in children aged 1 to under 12 years. This Phase 3 randomized, double-blind, placebo-controlled trial aims to evaluate how well the vaccine works and its safety profile in young children against Chikungunya virus infection. Participants will be randomly assigned to one of four groups two active vaccine groups and two placebo groups. The CHIKV VLP vaccine contains chikungunya virus-like particles combined with an aluminum hydroxide adjuvant. The study includes multiple visits for vaccination and follow-up, with immune responses measured at several time points including Days 15, 22, 183, 366, and 732 after vaccination. Safety is monitored throughout via reports of adverse events and serious events. Children in the study will attend scheduled visits to receive the vaccine or placebo and undergo assessments including blood tests to measure immune response. Researchers will track any side effects from vaccination up to two years after the first dose. The main outcomes focus on immune response by Day 22 and safety events throughout the study. Participants health and adherence to study visits will be closely monitored during the entire trial period, which lasts up to approximately two years.

Researchers are evaluating the safety, side effects, and effectiveness of brenipatide LY3537031 in adults with Irritable Bowel Syndrome-Diarrhea IBS-D. The study compares brenipatide administered under the skin with a placebo to understand its impact on this condition. This Phase 2 clinical trial involves participants aged 18 to 75 years. Participants will receive either the study drug brenipatide or a placebo through subcutaneous injections. The study follows a randomized, double-blind design where neither participants nor researchers know which treatment is given. Treatment and placebo administrations occur during the trial, which lasts approximately 35 weeks. During the study, participants will be monitored for how well they tolerate the drug and any side effects. Researchers will collect daily data on abdominal pain and stool consistency using an eDiary, focusing on responses between weeks 9 and 24. The primary measure is the percentage of participants achieving a daily composite response for at least half the days between weeks 9 and 16. Safety and efficacy outcomes are tracked throughout the trial period.

Researchers are evaluating the safety and preliminary effectiveness of SER-155, an experimental live bacterial therapeutic, as a first treatment for people experiencing diarrhea related to immunotherapy-induced enterocolitis irEC. This study focuses on adults with grade 2-3 diarrhea due to irEC who have not received immunosuppressive therapy before. The trial aims to find out if SER-155 causes few or mild side effects while addressing these symptoms. Participants will receive SER-155 orally, which consists of 16 unique human-commensal bacterial strains encapsulated for ingestion. The study is single-arm and open-label, meaning all participants will receive this experimental treatment without a comparison group. The treatment and observation will last up to one year, with assessments at various time points including days 15 and 43. During the study, participants will be monitored for treatment-related side effects and clinical responses to irEC without immunosuppressive drugs. Researchers will collect data on adverse events, treatment response and remission rates, and bacterial strain detection in the participants. The study involves regular assessments over a year to carefully track safety and treatment outcomes.

This research aims to understand the training experience of senior general surgery residents in advanced gastrointestinal GI surgical procedures during residency. It focuses on identifying who provides this training and assessing residents self-reported comfort and competence in performing both common and complex GI surgeries. The study highlights the importance of evaluating the need and interest in an Advanced GI Surgical fellowship among senior residents as they consider further specialized training or beginning independent practice. Participants include fourth and fifth year general surgery residents in accredited residency programs across the United States. The study collects data through an anonymous survey about their training in advanced GI procedures and their comfort level with managing GI surgical pathologies. This observational study does not involve any medical interventions or treatments. Throughout the study, participants complete surveys that assess their training experiences and confidence in GI surgical skills. Researchers analyze these responses to better understand educational gaps and fellowship needs. The primary outcome is focused on the training of senior general surgical residents over one year. Participation involves completing the survey without any active treatment or procedures, and the study is conducted anonymously to ensure privacy.

Researchers are studying gut and digestive health by evaluating changes before and after using a dietary supplement system for eight weeks. This study focuses on adults aged 18 to 80 years who have self-reported gastrointestinal symptoms. The goal is to understand how the supplement affects gut microbiota, inflammation, immune activity, and digestive function, which are important for overall health and well-being. Participants will take a dietary supplement system consisting of two products, PhytoPower 1 and PhytoPower 2, daily for eight weeks. They will mix one stick pack of each product into 16 fluid ounces of water and drink it each morning, with or without food. The study is open-label and single-arm, meaning all participants receive the supplement while maintaining their usual diet and lifestyle. During the study, participants will provide stool samples at the beginning and end to measure various biomarkers related to gut microbial diversity, inflammation, immune activity, digestion, and intestinal barrier integrity. They will also complete questionnaires about gastrointestinal symptoms and digestive well-being at several points throughout the study. Safety and tolerability will be monitored by tracking adverse events and compliance, with the total participation lasting eight weeks.

Researchers are evaluating the efficacy, immune response, and safety of the CHIKV VLP vaccine to prevent Chikungunya disease in adolescents and adults aged 12 years and older. This phase 3b study uses advanced infectious disease models and analytics to select regions and clinical sites, set study timelines, and optimize study parameters against local Chikungunya virus conditions to address challenges in assessing vaccine efficacy. Participants will be randomly assigned to receive either the CHIKV VLP vaccine with an adjuvant or a placebo. The vaccine consists of a 0.8 mL intramuscular injection containing 40 g of CHIKV VLP adsorbed on aluminum hydroxide. The study includes two groups one receiving the active vaccine and one receiving placebo. It follows participants from 14 days after vaccination up to 1095 days to assess disease prevention and immune response. During the study, participants will be monitored for confirmed acute, chronic, and severe Chikungunya disease cases. Safety is tracked by recording local and unsolicited adverse events up to 28 days postvaccination and serious or medically attended events throughout the study. Blood samples will measure antibody responses at three weeks postvaccination. The total study duration is up to three years, allowing detailed follow-up on vaccine effects and safety.

Researchers are conducting an international observational study to understand acute infectious diseases in adults hospitalized with suspected or confirmed infections. This study aims to collect data and biospecimens from patients worldwide to characterize respiratory and non-respiratory infections, established infectious diseases, and emerging infectious diseases. The information gathered will help identify risk factors, clinical features, and management strategies, and guide future clinical trials. Participants in this study are adults admitted to a hospital with an acute infection or suspected infection. There is no intervention or treatment given as part of the study since it is observational. The study focuses on collecting clinical data and biospecimens during hospitalization to better understand the disease processes and outcomes. During the study, participants will be monitored for clinical outcomes such as mortality at 28 days, time to recovery, clinical improvement, organ support requirements, and organ failure scores. Data collection includes clinical assessments and biospecimen sampling. The study will continue until June 2027, with participants followed for outcomes mainly up to 28 days after enrollment. This observational approach supports the development of future clinical trials by providing detailed insights into acute infections.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.