Clostridium Difficile Infection

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 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.

Researchers are exploring whether the virus that causes COVID-19, called SARS-CoV-2, is present in the stool of infected patients. The study aims to understand the role of gut flora during and after COVID-19 infection by examining stool samples for viral shedding. This non-interventional pilot study is led by ProgenaBiome and focuses on the gastrointestinal microbiome in people diagnosed with COVID-19. Participants will provide stool samples that will be analyzed to sequence the microbiome. Samples will be collected during treatment for COVID-19 and again after treatment to determine if and when the virus is shed in the stool. The study involves observing the general populations microbiome through these samples without any intervention or treatment imposed. During the study, participants will have their stool microbiome sequenced to analyze the relative abundance of microbes and correlate it with the disease over the course of one year. Researchers will validate sequencing methods and monitor the gut microbiome changes. The study includes follow-up assessments and does not involve any active treatment, focusing instead on data collection and analysis over the study period.

Researchers are evaluating the safety, efficacy, and tolerability of ibezapolstat ACX-362E in adults with recurrent Clostridioides difficile infection CDI who have experienced three or more episodes within the past year. This Phase 2, open-label, single-arm study focuses on treatment and reducing CDI recurrence in this patient group. Participants will receive ibezapolstat 450 mg orally every 12 hours with food for 14 days, totaling 28 doses. Up to 20 participants will be treated and monitored through multiple follow-up points to assess clinical cure on Day 16, sustained clinical cure on Day 42, and CDI recurrence rates up to Week 24. Extended clinical cure will also be evaluated during this period. During the study, participants will be closely monitored for clinical response, recurrence of infection, and changes in the fecal microbiome. Researchers will assess time to diarrhea resolution and track safety and tolerability. Follow-up visits will continue through Week 24 to evaluate long-term outcomes and sustained treatment effects.

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 investigating the safety and effectiveness of adding Toxclean, a powder developed by ABResearch srl, to standard therapy for adults with recurrent Clostridium Difficile-associated diarrhea CDAD. This exploratory, randomized study focuses on patients who have experienced a new episode of diarrhea within two months after completing standard CDAD treatment, aiming to see if 1 or 2 grams of Toxclean can be taken orally and tolerated well alongside standard care. Participants will be randomly assigned to one of two groups one receiving 1 gram of Toxclean once daily for 28 days plus standard therapy, and the other receiving 1 gram twice daily for 28 days plus standard therapy. The study will assess the completion rate of Toxclean treatment, safety, tolerability, clinical response after 14 and 28 days, symptom improvements during and after treatment, and fecal Toxclean concentration. During the study, participants will be monitored through clinical assessments, fecal toxin measurements, and symptom tracking over a 28-day treatment period and follow-up lasting two months. Researchers will evaluate safety, tolerance, and effectiveness of Toxclean combined with standard therapy. The total study duration includes treatment and follow-up, with participant progress closely observed by the study team.

Researchers are studying how changes in the gut microbiome relate to hormonal changes during womens ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for womens health. Participants are grouped by menopausal stage premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausalpostmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in womens health.

Researchers are evaluating the use of oral alanyl-glutamine AQ supplementation alongside standard therapy to treat Clostridioides difficile infection CDI in adults aged 18 and older. This Phase II, randomized, double-blind, placebo-controlled trial aims to determine the optimal dose and safety of AQ given in doses of 0, 4, 24, or 44 grams daily for 10 days. The study hypothesizes that AQ may reduce CDI recurrence and mortality while improving inflammatory markers and intestinal microbiota function. Participants are randomly assigned to one of four groups receiving AQ at 4, 24, or 44 grams or a placebo, administered once daily orally or through a feeding tube if needed. The treatment lasts 10 days and is given alongside standard antibiotics such as oral vancomycin or fidaxomicin. The trial uses block randomization to maintain balance over the enrollment period and follows participants daily during treatment and weekly for 60 days afterward to monitor for recurrence and survival. During the study, researchers collect blood, urine, and stool samples at the start, after 10 days, and at 70 days to analyze inflammation and microbial changes. Participants may attend in-person or virtual visits, with options for sample shipment if needed. Safety is closely monitored throughout treatment and follow-up. The main outcome measured is the number of participants with recurrent CDI within 60 days post-treatment, with mortality as a secondary outcome. The total participation period covers treatment and 60 days of follow-up.

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.