Literature DB >> 32053787

Regulatory Considerations for Fecal Microbiota Transplantation Products.

Paul E Carlson1.   

Abstract

Fecal microbiota for transplantation (FMT) is being studied as a potential intervention for numerous conditions. The regulation of FMT by the FDA is discussed along with FMT donor screening and manufacturing considerations. The FDA is committed to ensuring that FMT products can be safely tested in clinical trials. Published by Elsevier Inc.

Entities:  

Year:  2020        PMID： 32053787     DOI： 10.1016/j.chom.2020.01.018

Source DB:  PubMed          Journal:  Cell Host Microbe        ISSN： 1931-3128            Impact factor:   21.023


  9 in total

1.  Batch Culture Formulation of Live Biotherapeutic Products.

Authors:  Kunyu Qiu; Aaron C Anselmo
Journal:  Adv Ther (Weinh)       Date:  2020-11-23

2.  SER-109, an Investigational Microbiome Drug to Reduce Recurrence After Clostridioides difficile Infection: Lessons Learned From a Phase 2 Trial.

Authors:  Barbara H McGovern; Christopher B Ford; Matthew R Henn; Darrell S Pardi; Sahil Khanna; Elizabeth L Hohmann; Edward J O'Brien; Christopher A Desjardins; Patricia Bernardo; Jennifer R Wortman; Mary-Jane Lombardo; Kevin D Litcofsky; Jonathan A Winkler; Christopher W J McChalicher; Sunny S Li; Amelia D Tomlinson; Madhumitha Nandakumar; David N Cook; Roger J Pomerantz; John G Auninš; Michele Trucksis
Journal:  Clin Infect Dis       Date:  2021-06-15       Impact factor: 9.079

3.  Host immunity modulates the efficacy of microbiota transplantation for treatment of Clostridioides difficile infection.

Authors:  Eric R Littmann; Jung-Jin Lee; Joshua E Denny; Zahidul Alam; Jeffrey R Maslanka; Isma Zarin; Rina Matsuda; Rebecca A Carter; Bože Susac; Miriam S Saffern; Bryton Fett; Lisa M Mattei; Kyle Bittinger; Michael C Abt
Journal:  Nat Commun       Date:  2021-02-02       Impact factor: 14.919

Review 4.  Crosstalk between Gut and Brain in Alzheimer's Disease: The Role of Gut Microbiota Modulation Strategies.

Authors:  Umair Shabbir; Muhammad Sajid Arshad; Aysha Sameen; Deog-Hwan Oh
Journal:  Nutrients       Date:  2021-02-21       Impact factor: 5.717

5.  A comprehensive approach to stool donor screening for faecal microbiota transplantation in China.

Authors:  Jianquan He; Xingxiang He; Yonghui Ma; Luxi Yang; Haiming Fang; Shu Shang; Huping Xia; Guanghui Lian; Hailing Tang; Qizhi Wang; Junping Wang; Zhihui Lin; Jianbo Wen; Yuedong Liu; Chunbao Zhai; Wen Wang; Xueliang Jiang; Ji Xuan; Morong Liu; Shiyun Lu; Xuejun Li; Han Wang; Cong Ouyang; Man Cao; Aiqiang Lin; Bangzhou Zhang; Depei Wu; Ye Chen; Chuanxing Xiao
Journal:  Microb Cell Fact       Date:  2021-11-27       Impact factor: 5.328

Review 6.  Next-generation sequencing: insights to advance clinical investigations of the microbiome.

Authors:  Caroline R Wensel; Jennifer L Pluznick; Steven L Salzberg; Cynthia L Sears
Journal:  J Clin Invest       Date:  2022-04-01       Impact factor: 14.808

Review 7.  Are the Effects of Malnutrition on the Gut Microbiota-Brain Axis the Core Pathologies of Anorexia Nervosa?

Authors:  Stein Frostad
Journal:  Microorganisms       Date:  2022-07-24

8.  A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, for Active Mild to Moderate Ulcerative Colitis.

Authors:  Matthew R Henn; Edward J O'Brien; Liyang Diao; Brian G Feagan; William J Sandborn; Curtis Huttenhower; Jennifer R Wortman; Barbara H McGovern; Sherry Wang-Weigand; David I Lichter; Meghan Chafee; Christopher B Ford; Patricia Bernardo; Peng Zhao; Sheri Simmons; Amelia D Tomlinson; David N Cook; Roger J Pomerantz; Bharat K Misra; John G Auninš; Michele Trucksis
Journal:  Gastroenterology       Date:  2020-08-04       Impact factor: 22.682

9.  Stool Banking for Fecal Microbiota Transplantation: Methods and Operations at a Large Stool Bank.

Authors:  Justin Chen; Amanda Zaman; Bharat Ramakrishna; Scott W Olesen
Journal:  Front Cell Infect Microbiol       Date:  2021-04-15       Impact factor: 5.293
  9 in total

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