139 results about "Clostridium difficile infections" patented technology

There are provided novel synthetic stool preparations comprising bacteria isolated from a fecal sample from a healthy donor. The synthetic stool preparations are used for treating disorders of the gastrointestinal tract, including dysbiosis, Clostridium difficile infection and recurrent Clostridium difficile infection, prevention of recurrence of Clostridium difficile infection, treatment of Crohn's disease, ulcerative colitis, irritable bowel syndrome, inflammatory bowel disease, and diverticular disease, and treatment of food poisoning such as salmonella. Methods of preparation and methods of use of the synthetic stool preparations are also provided.

The present invention relates to the development of a targeted delivery system for the oral delivery of probiotics or therapeutic agent for various indications, including and not limited to active and prophylaxis treatment of Clostridium difficile infection, antibiotic associated diarrhea, irritable bowel syndrome, Crohn's disease, intestinal flora replacement, supplemental flora treatments for patients taking antibiotics, and for restoration of balance and signaling between the intestinal microbiome and the intestinal cells in patients under treatment of metabolic syndrome manifestations, specifically diabetes, insulin resistance, obesity, hyperlipidemia and hypertension.

The invention provides active and passive immunization methods for preventing and treating Clostridium difficile infection, which involve percutaneous administration of C. difficile toxin-neutralizing polyclonal immune globulin, C. difficile toxoids, or combinations thereof. Also provided by the invention are C. difficile toxoids, C. difficile toxin-neutralizing polyclonal immune globulin, and methods of identifying subjects that produce C. difficile toxin-neutralizing polyclonal immune globulin.

Methods and compositions for targeted delivery of biotherapeutics are provided. The compositions comprise bile-sensitive St. thermophilus bacteria modified to release a biotherapeutic agent following bile exposure. Biotherapeutic agents released by the St. thermophilus bacteria disclosed herein include AQ and AQR rich peptides. Methods of the invention comprise administering to a subject a St. thermophilus bacterium modified to release a biotherapeutic agent following bile exposure. Administration of the St. thermophilus bacterium promotes a desired therapeutic response. The bacterium may be modified to express and release AQ or AQR rich peptides which subsequently inhibit cellular apoptosis or reduce mucosal damage. Thus, methods of the invention find use in treating or preventing a variety of gastrointestinal disorders including C. difficile infection and antibiotic-associated diarrhea.

A provided multiple fluorescence PCR detection kit for clostridium difficile toxin genes mainly comprises specific primers, probes and a PCR reaction reagent, and the specific primers and the probes respectively consist of specific primers and probes of clostridium difficile toxin A (tcdA), toxin B (tcdB), binary toxin A (cdtA) and binary toxinB (cdtB). The beneficial effects of the invention comprise: the fast, sensitive and specific multiple fluorescence PCR detection kit and a detection method are provided for the clostridium difficile toxin genes, and a foundation is provided for distinguishing between toxigenic strains and avirulent strains of clostridium difficile, and early diagnosis on infection of clostridium difficile.

An active, or passive vaccine utilizing purified non-toxic mutant TcdB toxins from Clostridium difficile for humans and animals against infections caused by C. difficile and / or C. sordellii. Persons most potentially affected by C. difficile infections include hospitalized patients, infants, and elderly persons. The TcdB toxin mutant of the vaccine preferably lacks the toxicity of a native C. difficile TcdB toxin. A serum comprising antibodies raised to the TcdB toxin mutant is also available for treating humans or animals against C. difficile infections. The serum may be used in a method for conferring passive immunity against C. difficile. Antibodies to the TcdB toxin mutant may be used in diagnostic tests or in treatments to clear TcdB toxin from bodily fluids. The mutant TcdB toxin may be produced by recombinant methods using cDNA encoding the toxin, the cDNA contained for example in a plasmid or host cell.

The invention includes a formulation comprising: (i) a therapeutically effective amount of at least one antibiotic; and (ii) a therapeutically effective amount of at least one probiotic material. The formulation is prepared in a dosage form for delivery to the gastrointestinal tract. The invention further includes a method of preventing or minimizing the proliferation of Clostridium difficile in the gastrointestinal tract of a mammal undergoing an antibiotic therapy comprising by administration of the formulation of the invention for the duration of the antibiotic therapy; methods of preventing or minimizing the occurrence of antibiotic-associated diarrhea in a mammal undergoing an antibiotic therapy that includes administering the formulation; and methods of preventing or minimizing the occurrence of antibiotic-associated colitis or pseudomembranous colitis in a patient undergoing an antibiotic therapy that includes administering the formulation.Also included are methods of reducing or preventing a failure of treatment for an antibiotic-treatable infection in a patient comprising orally administering the formulation.Described by the invention are formulations for the treatment of a C. difficile infection comprising: (i) a therapeutically effective amount of at least one antibiotic; and (ii) a therapeutically effective amount of at least one probiotic material. The antibiotic includes a non-systemic gram negative antibiotic (such as, for example, fodaximicin) and formulation is prepared in a dosage form for delivery to the gastrointestinal tract.Also included are methods of treatment of a C. difficile infection in mammal that include administering to the digestive tract of the mammal the above described formulation. Such methods provide that the likelihood that the mammal shall experience a reoccurrence of the C. difficile infection is 70% or less.

The present invention relates generally to the 18-membered macrocyclic antimicrobial agents called Tiacumicins, specifically, OPT-80 (which is composed almost entirely of the R-Tiacumicin B), pharmaceutical compositions comprising OPT-80, and methods using OPT-80. In particular, this compound is a potent drug for the treatment of bacterial infections, specifically C. difficile infections.

The invention provides a test strip for rapid detection of clostridium difficile toxins A and B. A monoclonal antibody or polyclonal antibody of the clostridium difficile toxin A, a monoclonal antibody or polyclonal antibody of the clostridium difficile toxin B, and a quality control double-antibody IgG coat a nitrate cellulose film (NC film), and a membrane chromatography double antibody sandwich method is adopted to detect the clostridium difficile toxins A and B in a specimen in combination with a monoclonal antibody of colloidal gold labeled clostridium difficile toxins A and B. The test strip is simple in operation, convenient, and fast, and has the advantages of no requirements of special instruments and special training, clear and identified result, and easy popularization. The test strip is suitable for base course, site detection and epidemiological investigation, and has auxiliary effect on the diagnosis of clostridium difficile toxin infection.

Provided is an application of natural faeces flora transplanting in intestinal disease treatment. Faeces of healthy people screened through multiple conditions is collected, intestinal canal mixed probiotic flora is collected through the steps of homogenating, suspending, diluting, filtering, centrifuging and the like and transplanted in the ways of a gastroscope, an enteroscope, a nose-jejunum tube, a fistulization opening, clysis and the like, flora balance in the intestinal canal is restored, and the effect of treating intestinal diseases is achieved. A method for treating bacteria with bacteria is adopted, the stability of the intestinal flora of a human body is maintained, a microecological treating method free of drug resistance and toxic and side effects is achieved, treatment is carried out in the mode of faeces bacterium capsules or bacterium liquid, and a good treatment effect is achieved on diarrhea, clostridium difficile infection, Crohn's diseases and the like.

The invention features compounds of formula (I): The compounds are useful as antibacterial agents, especially again Clostridium difficile-associated diseases.

This invention relates to prophylactic and / or therapeutic application of microorganism species that are, for example, administered orally as delayed release formulation designed to release its microbial content to the distal small intestine and / or colon in high quantities and density, which is a “normalized” approach to repopulate the colonic flora as a method of prevention and / or treatment of, for example, Clostridium difficile colitis.

The present invention relates to the development of a targeted delivery system for the oral delivery of probiotics or therapeutic agent for various indications, including and not limited to active and prophylaxis treatment of Clostridium difficile infection, antibiotic associated diarrhea, irritable bowel syndrome, Crohn's disease, intestinal flora replacement, supplemental flora treatments for patients taking antibiotics, and for restoration of balance and signaling between the intestinal microbiome and the intestinal cells in patients under treatment of metabolic syndrome manifestations, specifically diabetes, insulin resistance, obesity, hyperlipidemia and hypertension.

The present invention relates generally to the 18-membered macrocyclic antimicrobial agents called Tiacumicins, specifically, OPT-80 (which is composed almost entirely of the R-Tiacumicin B), pharmaceutical compositions comprising OPT-80, and methods using OPT-80. In particular, this compound is a potent drug for the treatment of bacterial infections, specifically C. difficile infections.

The present invention relates to recombinant C. difficile toxin A (TcdA) and toxin B (TcdB) and binary toxin A (CDTa) proteins comprising specifically defined mutations relative to the native toxin sequence that substantially reduce or eliminate toxicity. The invention also relates to vaccines and immunogenic compositions comprising these recombinant toxins, as well as combinations of these toxins with binary toxin B (CDTb), which are capable of providing protection against C. difficile infection and / or the effects thereof. The invention also relates to methods of inducing an immune response to C. difficile comprising administering the vaccines and immunogenic compositions described herein to a patient. The invention also encompasses methods of expressing recombinant C. difficile toxin A and toxin B and CDTa mutants and CDTb in recombinant expression systems. In exemplary embodiments, TcdA, TcdB, and CDTa mutant toxins comprising sufficient mutations to substantially reduce or eliminate toxicity are expressed in the baculovirus / insect cell expression system.

The present invention relates to methods and compositions for reducing the risk and severity of C. difficile infection. It is based, at least in part, on the discovery that a restricted fraction of the gut microbiota, including the bacterium Clostridium scindens, contributes substantially to resistance against C. difficile infection. Without being bound by any particular theory, it is believed that this is achieved through the biosynthesis of secondary bile acids.

Various types of synbiotic therapies are provided for the treatment of a variety of gastrointestinal and other disorders. The combination of prebiotics to probiotics is defined as a synbiotic therapy. The principal GI disorders associated with dysbiosis that can be treated from such a therapeutic intervention include but are not limited to: inflammatory bowel disease (IBD) (Crohn's disease and ulcerative colitis), irritable bowel syndrome (IBS), antibiotic-associated diarrheas such as recurrent Clostridium difficile infection, and possibly variants of Celiac disease. Other disorders that may also be ameliorated by the proposed synbiotic therapy include metabolic syndromes and central nervous system disorders. The disclosed methods and compositions were developed to improve upon currently available probiotics through consideration of the human intestinal microbiota, and its relationship to various intestinal metabolic and neuropsychiatric disorders. In one embodiment, the disclosed synbiotic compositions include prebiotics and a targeted delivery system, which altogether promote the survival, growth, and attachment of probiotic microbiota.

Embodiments of the invention include methods and / or compositions for analysis of samples for C. difficile infection to determine whether or not an individual is at risk for having recurrent C. difficile infection or a CDI misdiagnosis. Methods include characterization of microflora composition from the gut, wherein alterations of the microflora gut composition are indicative of recurrence of infection. Methods include analysis of nucleic acids from the gut, such as 16S rRNA as being identifying of a particular bacteria in the analysis of bacterial populations of the gut.

The present invention provides methods for the treatment or prophylaxis of a microbial infection of the lower intestine or colon in a subject, the method comprising administering to the subject a type-B lantibiotic. In particular, the invention provides methods for the treatment or prophylaxis of a Clostridium difficile infection. The type-B lantibiotics may include compounds selected from the group consisting of mersacidin, actagardine, plantaricin, planosporicin, ruminococcin, antibiotic 10789, michiganin and haloduracin, and derivatives and variants thereof.

Embodiments include methods for generating a metabolite profile of a stool sample and methods of assessing the status of a subject using the metabolic profile derived from a stool sample.

Provided are compositions and methods for prophylaxis and / or therapy of C. difficile infection, and for inhibiting dissemination of C. difficile spores. The compositions contain C. difficile proteins, including distinct proteins and fusions of C. difficile CD 1067, BclA1, SleC, CotA, Spl7, FliC, FliD, CD toxin A, CD toxin B, and combinations thereof. The methods include prophylaxis and / or therapy of C. difficile infection by administering to a subject in need a composition that includes the C. difficile protein(s).

Novel compounds in enantiomeric excess that are inhibitors of bacterial methionyl synthetase (MetRS) are disclosed. Also disclosed are methods for their preparation and their use in therapy as antibacterial agents, and in particular their use in therapy for Clostridium difficile infection.

The present invention relates to methods and compositions for the treatment and / or prophylaxis of Clostridium difficile associated disease (CD AD). In particular, the invention relates to antibodies that bind to C. difficile antigens and are capable of inhibiting C. difficile infection, at least one symptom of C. difficile associated disease, shedding of C. difficile, and C. difficile associated mortality. The compositions of the present application comprise: mammalian or avian antibodies which bind to a C. difficile Toxin B; and mammalian or avian antibodies that bind to a C. difficile vegetative cell antigen and / or a C. difficile endospore antigen.

Novel compounds in enantiomeric excess that are inhibitors of bacterial methionyl synthetase (MetRS) are disclosed. Also disclosed are methods for their preparation and their use in therapy as antibacterial agents, and in particular their use in therapy for Clostridium difficile infection.

This invention relates to, in part, compositions of beta-lactamases and methods of using these enzymes in, for example, gastrointestinal tract (GI tract) disorders such as C. difficile infection (CDI).

The invention discloses a fluorescent quantitative PCR detection kit for clostridium difficile toxin A / B by adopting a probe method, and a detection method, which can detect clostridium difficile and also can detect and quantify toxin A and B genes. The detection kit mainly comprises specific primers and probes, wherein the specific primers and the probes are composed of primer pairs for detecting clostridium difficile, primer pairs and probes for detecting clostridium difficile toxin A, as well as primer pairs and probes for detecting clostridium difficile toxin B. According to the detection kit and the detection method, the operation is simple, the report time is short, the clostridium difficile strains can be specifically, sensitively and accurately identified for the first time, and the key toxins A and B of clostridium difficile are detected and quantified. A foundation is laid for the early diagnosis for clostridium difficile infection, and the detection kit and the detection method are suitable for screening causes of diarrhea patients with unknown causes clinically.

The present invention provides fully human antibodies that bind to either toxin A or toxin B of Clostridium difficile, or to both toxin A and toxin B, compositions comprising the antibodies and methods of use. The antibodies of the invention are useful for neutralizing the toxins from C. difficile, thus providing a means of treating the disease and symptoms associated with a C. difficile infection, including the treatment of diarrhea, or pseudomembranous colitis caused by C. difficile. The antibodies may also prevent the severity and / or duration of the primary disease, or may prevent the number, duration, and / or the severity of recurrences, or relapses of the disease attributed to the presence of C. difficile. The antibodies of the invention may also be useful for diagnosis of an infection by C. difficile.

Provided herein are analog and derivative compounds of inositol hexakisphosphate effective to treat a Clostridium difficile infection and to neutralize the bacterial toxins produced by the same. In addition, methods of treating the C. difficile infection and for neutralizing its toxins with the compounds are provided.