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 drug's 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, 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 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 population's 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.

This research aims to understand who teaches gastrointestinal (GI) surgical procedures to senior general surgery residents during their training and to assess the residents' comfort level with performing both common and complex GI procedures. It also seeks to explore the need and interest for an Advanced Surgical GI fellowship among these senior residents. The study is observational and focuses on fourth and fifth year general surgery residents in accredited programs in the United States. The study involves an anonymous survey to collect information about the training sources for advanced GI surgical procedures and how confident senior surgical residents feel in performing these procedures after residency. There are no experimental treatments; instead, the survey gathers data regarding training experiences and residents' self-reported competence. The survey aims to provide insights into residency training and fellowship interest over a one-year period. Participants will complete the anonymous survey, sharing their experiences and comfort levels with GI surgery training. Researchers will analyze this information to better understand training adequacy and fellowship needs. The primary outcome measure is the training of senior general surgical residents over one year. No medical procedures or interventions are performed as part of this study, and participation involves only survey completion.

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 women's 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 women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal 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 women's 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.

Researchers are conducting a Phase 1 pilot clinical trial to evaluate the safety and feasibility of an oral preparation of fecal microbiota (MTP-101P) in patients undergoing colon resection. This study includes adults aged 18 to 75 who have colon polyps, early-stage colorectal cancer (stage I or II), or medically refractory diverticulitis. The research aims to gather initial data on donor microbiota engraftment and its pharmacokinetics to help design future trials for colon and rectal surgery treatments. Participants will receive a suspension of freeze-dried fecal microbiota taken orally after surgery, specifically 48 hours following intravenous antibiotics given at the time of surgery. Prior to surgery, patients will also receive standard bowel preparation and oral antibiotics. The treatment involves a single experimental group receiving MTP-101P, composed of highly purified microbiota from healthy donors. During the trial, participants will provide stool samples that may be mailed in rather than submitted in person. Researchers will monitor the microbiome changes over time, focusing on the engraftment of donor microbiota by analyzing diversity measures until day 180. Participants will have follow-up through telephone, in-person, email, or video visits to comply with study procedures and monitor safety and outcomes throughout the duration of the trial.