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NCT06237452
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
NCT04003818
Primary Objective: Explore the efficacy of teicoplanin (100-200 mg administered orally twice a day for 7 to 14 days) in patients with Clostridium difficile infection-associated diarrhea and colitis Secondary Objective: Evaluate the safety of teicoplanin in patients with Clostridium difficile infection-associated diarrhea and colitis
NCT04171817
Hospital-based Animal-Assisted visitation programs are important complementary therapies, but concerns with infection control may challenge the sustainability of these programs. Pilot data suggest that a low-cost chlorhexidine-based intervention targeted to the dogs involved in the visitation programs holds high potential to prevent pathogen transmission during sessions. In this study, the following aims will be tested: 1) To identify program-related risk factors for acquisition of hospital-associated pathogens by pediatric patients during animal-assisted intervention (AAI) sessions during an initial run-in phase of no intervention; 2) To determine the effect of chlorhexidine (CHX)-based interventions on acquisition of hospital-associated pathogens and microbial communities by patients during AAI sessions via a multicenter randomized controlled trial; and 3) To determine whether the specific benefits achieved by the visitation program, i.e. reduction in blood pressure, heart rate and self-reported pain and anxiety, are impacted by the interventions.
NCT05826418
Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.
NCT04100603
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
NCT03350711
The goal of this study is to rapidly identify subjects who are eligible for the Microbiota Enrichment Program (MEP) at Emory in Atlanta, Georgia. This general screening protocol will be used to screen potential subjects for the Emory MEP and will be conducted at the Emory Clinic, the Hope Clinic of the Emory Vaccine Center and/or Emory affiliated hospitals. An electronic database will be created to capture demographic and medical information about individuals who are reaching out to obtain fecal microbiota transplant (FMT) and pre-screen these potential study participants for current and upcoming studies within MEP.
NCT02636517
Fecal Microbiota Transplant (FMT) in pediatric patients with recurrent C. Difficile with or without Inflammatory Bowel Disease (IBD) The aims of this study are to determine the safety and efficacy of FMT treatment in pediatric patients with recurrent or moderate to severe C. Difficile without (through an observational study) and with (through a clinical trial) Inflammatory Bowel Disease and to determine the effect of FMT on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.
NCT06839209
This is a single center, randomized, exploratory clinical investigation that will evaluate the safety and efficacy of Toxclean (ABResearch srl) as add on treatment to Standard therapy in 24 patients with recurrent CDAD. Eligible subjects will be adult patients with recurrent CDAD. Recurrent CDAD, for the purpose of this protocol, is defined as one or more new episode of diarrhea (Ned) within two months from the end of the SoC treatment. The objective of this pilot study is to evaluate whether 1 or 2 grams of Toxclean powder is orally administrable and well tolerated as add on treatment to SoC in patients with recurrent CDAD.
NCT01983683
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
NCT01987895
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
NCT03617445
The objective is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.
NCT02179658
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
NCT04014413
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.
NCT06398379
Fecal Virome Transplantation (FVT) has in small studies shown benefit in the treatment of recurrent C. difficile infection. In the VISION study we will treat patients with recurrent C. difficile infection with FVT capsules and compare the treatment with Fecal Microbiota Transplantation (FMT) capsules. Both will be following af standard treatment of antibiotics (Vancomycin)
NCT04090346
The study will provide data to show the effectiveness of Fecal Microbiota Transplant in patients with recurrent Clostridium difficile infection. Fecal Microbiota Transplant (FMT) is a procedure in which healthy colon contents of a carefully screened donor is inserted into the colon of a compromised patient. FMT is a procedure to replace beneficial bacteria that has been killed or suppressed, most commonly by use of antibiotics. Currently it is utilized as an experimental treatment for Clostridium difficile infection (CDI). This procedure is predicted to reduce the cost both financially and physically for the CDI patient and facility.
NCT02016820
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.
NCT03970200
This is a randomized, open label, comparative, Phase II study to determine whether fecal microbiota transplant using Penn Microbiome Therapy products helps standard therapy to treat severe Clostridium difficile infection (C diff).
NCT02830542
The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).
NCT03579459
This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
NCT03760484
Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI. Current evidence suggests that FMT in combination with vancomycin is required, and that multiple treatments are necessary. The investigators think fidaxomicin may be a better option in the context and may potentially reduce the number of FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to determine efficacy and safety in treating patients with severe or fulminant CDI. The investigators want to see if this approach may reduce the number of FMT treatment required, and/or the length of hospital stay.