MSGID: 1:317/3 64a79505   
   PID: hpt/lnx 1.9.0-cur 2019-01-08   
   TID: hpt/lnx 1.9.0-cur 2019-01-08   
    Demonstration of safety of microbiota transplant therapy in stem cell   
   transplant and leukemia patients    
      
     Date:   
         July 6, 2023   
     Source:   
         University of Minnesota Medical School   
     Summary:   
         A new study has demonstrated the safety of using microbiota   
         transplant therapy (MTT) in patients with acute myeloid leukemia   
         (AML) -- a type of blood cancer -- and recipients of hematopoietic   
         cell transplantation (HCT).   
      
      
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   Published in theJournal of Clinical Oncology, University of Minnesota   
   Medical School researchers led a study that demonstrated the safety   
   of using microbiota transplant therapy (MTT) in patients with acute   
   myeloid leukemia (AML) -- a type of blood cancer -- and recipients of   
   hematopoietic cell transplantation (HCT).   
      
   Current treatment for patients with AML and who receive HCT includes   
   powerful chemotherapy, which can damage their immune system and intestinal   
   lining.   
      
   Because of this, patients typically require antibiotics to fight and   
   prevent infections. These antibiotics also kill healthy gut microbes,   
   which may worsen treatment outcomes. The goal of MTT is to restore   
   beneficial microbes in the recipient's gut.   
      
   "Microbiota transplants are classified as drugs by the U.S. Food and   
   Drug Administration. However, they truly are an entirely different   
   and new class of drugs, and we need to develop and understand their   
   pharmacology. This requires standardized formulations and figuring out   
   the optimal dosing regimens," said Alexander Khoruts, MD, director of   
   the University of Minnesota Microbiota Therapeutics Program.   
      
   In a randomized, double-blind study, the research team compared the   
   outcomes of MTT for two groups: patients with AML and HCT recipients. They   
   used a novel, standardized preparation of donor microbiota called   
   MTP-101C, which is formulated in capsules that are taken orally. After   
   each course of antibiotics, patients received either MTT or a placebo. The   
   study found the rate of infections was lower in HCT and AML patients   
   that received active MTT relative to the patients that received the   
   placebo. However, the difference did not reach statistical significance.   
      
   Overall, the study showed MTT was safe and partially improved the   
   imbalance of gut bacteria in patients who had received HCT or had   
   AML. However, it did not significantly reduce the rate of infections in   
   these patients.   
      
   These results will serve as the basis for a larger follow-up study, which   
   will use a more aggressive MTT protocol with the microbiota compound   
   manufactured by the University of Minnesota Microbiota Therapeutics   
   Program. The program has been the world leader in the development and   
   manufacturing of microbiota-based therapeutics over the past decade. It   
   is working to develop effective and practical restorative microbiota   
   therapies for multiple clinical indications, some of which include   
   infections with Clostridioides difficile, inflammatory bowel disease   
   and different applications in cancer.   
      
   This study was funded largely through local philanthropy, including the   
   Chainbreaker Cancer Fundraiser bike event held in 2017, as well as the   
   nonprofit Achieving Cures Together. Additional support was provided   
   by the National Institutes of Health's National Center for Advancing   
   Translational Sciences [KL2TR002492 and UL1TR002494] and the National   
   Cancer Institute [P30CA07759].   
      
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   Journal Reference:   
      1. Armin Rashidi, Maryam Ebadi, Tauseef Ur Rehman, Heba Elhusseini,   
      David   
         Kazadi, Hossam Halaweish, Mohammad H. Khan, Andrea Hoeschen,   
         Qing Cao, Xianghua Luo, Amanda J. Kabage, Sharon Lopez, Shernan   
         G. Holtan, Daniel J. Weisdorf, Alexander Khoruts, Christopher   
         Staley. Randomized Double- Blind Phase II Trial of Fecal Microbiota   
         Transplantation Versus Placebo in Allogeneic Hematopoietic Cell   
         Transplantation and AML. Journal of Clinical Oncology, 2023; DOI:   
         10.1200/JCO.22.02366   
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   Link to news story:   
   https://www.sciencedaily.com/releases/2023/07/230706124523.htm   
      
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