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  • ||||||||||  Cdactin-O (CBM-588) / Osel, Miyarisan
    Journal:  The Live Bacterial Product CBM588 Improves CPI Response in mRCC. (Pubmed Central) -  May 9, 2022   
    In conclusion CBM-B from CBM 588 is a potential inhibitor against C. difficile which could be used as therapeutic treatment for CDI. Combining the live bacterial product CBM588 with checkpoint inhibitors improved progression-free survival.
  • ||||||||||  Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Takeda, Exelixis, Ipsen, Cdactin-O (CBM-588) / Osel, Miyarisan
    A phase I trial to evaluate the biologic effect of CBM588 (Clostridium butyricum) in combination with cabozantinib plus nivolumab for patients with metastatic renal cell carcinoma (mRCC). (Available On Demand; 93a) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_2536;    
    P1
    Moreover, recent evidence from a phase I clinical trial suggests that the addition of CBM588, a live probiotic comprised primarily of Clostridium butyricum, can enhance clinical response in patients with mRCC receiving nivolumab plus ipilimumab without incurring added toxicity (Meza et al ASCO, 2021)...Secondary objectives include determining the effect of CBM588 on (1) clinical efficacy, through overall survival, response rate, and progression-free survival; (2) systemic immunomodulation, through assessment of changes in circulating Tregs, circulating cytokines/chemokines, etc; and (3) toxicities. A two-group t-test with a one-sided type I error of 0.05 will be used to assess the study primary endpoint.
  • ||||||||||  Cdactin-O (CBM-588) / Osel, Miyarisan
    Review, Journal:  Effect of Clostridium butyricum on Gastrointestinal Infections. (Pubmed Central) -  Feb 26, 2022   
    Owing to its preventive and ameliorative effects on gastrointestinal infections, C. butyricum MIYAIRI 588 (CBM 588) has been used as a probiotic in clinical and veterinary medicine for decades...As C. butyricum is effective against gastrointestinal infections caused by antibiotics-induced dysbiosis, it can inhibit the transmission of antibiotic-resistant genes and maintain homeostasis of the gut microbiome. Altogether, C. butyricum is expected to be one of the antimicrobial-resistance (AMR) countermeasures for the One-health approach.
  • ||||||||||  Cdactin-O (CBM-588) / Osel, Miyarisan
    Journal:  The Effects of Enteral Nutrition on the Intestinal Environment in Patients in a Persistent Vegetative State. (Pubmed Central) -  Feb 26, 2022   
    We conducted a preliminary study to investigate the effects of EN on the intestinal environment in 10 patients in a persistent vegetative state (PVS) (n = 5 each in the EN and EN with probiotics; Clostridium butyricum MIYAIRI 588) groups compared with 10 healthy controls...These findings indicate that EN causes dysbiosis of the intestinal microbiota and an imbalance in some intestinal metabolites in patients in a PVS. Moreover, although C. butyricumMIYAIRI 588 improved the imbalance of some intestinal metabolites after EN, it did not prevent dysbiosis of the intestinal microbiota.
  • ||||||||||  Cdactin-O (CBM588) / Osel, Miyarisan
    Enrollment closed, Trial completion date, Trial primary completion date:  CBM588 in Improving Clinical Outcomes in Patients Who Have Undergone Donor Hematopoietic Stem Cell Transplant (clinicaltrials.gov) -  Feb 22, 2022   
    P1,  N=36, Active, not recruiting, 
    Moreover, although C. butyricumMIYAIRI 588 improved the imbalance of some intestinal metabolites after EN, it did not prevent dysbiosis of the intestinal microbiota. Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, Cdactin-O (CBM-588) / Osel, Miyarisan
    Journal:  Clostridium butyricum enhances colonization resistance against Clostridioides difficile by metabolic and immune modulation. (Pubmed Central) -  Nov 7, 2021   
    Additionally, CBM 588 upregulated T cell-dependent pathogen specific immunoglobulin A (IgA) via interleukin (IL)-17A producing CD4 cells and plasma B cells in the cLP, and Th17 cells in the cLP enhanced the gut epithelial barrier function. IL-17A and succinic acid modulations with CBM 588 enhance gut colonization resistance to C. difficile and protect the colon tissue from CDI.
  • ||||||||||  Cdactin-O (CBM-588) / Osel, Miyarisan
    A Randomized Open Label Pilot Study of Clostridium Butyricum Miyairi 588 (CBM588) in Recipients of Allogeneic Hematopoietic Cell Transplantation (GWCC - B206, Level 2) -  Nov 5, 2021 - Abstract #ASH2021ASH_1661;    
    P1
    However, had favorable microbial profile was detected as the pathogens Enterobacteriaceae, Clostridium baratii, and Clostridiodes difficile were reduced in the treatment group. (Figure 2) In summary, our data demonstrate the feasibility and safety of CBM588 administration during the peri-transplant period, which was associated with an intended biologic impact on the gut microbiome, and an early favorable sign of GI-GVHD incidence and HCT outcomes in this older population who underwent RIC HCT.