Category Archives: Microbiome/Microbiota Information

Research Seeks Greater Insight Into Whether Changes In the Composition and Function Of the Gut Microbiota Are Associated With Disease

 

 

 

 

Health and Disease Imprinted in the Time Variability of the Human Microbiome

Abstract

The animal microbiota (including the human microbiota) plays an important role in keeping the physiological status of the host healthy.

Research seeks greater insight into whether changes in the composition and function of the microbiota are associated with disease.

We analyzed published 16S rRNA and shotgun metagenomic sequencing (SMS) data pertaining to the gut microbiotas of 99 subjects monitored over time.

Temporal fluctuations in the microbial composition revealed significant differences due to factors such as dietary changes, antibiotic intake, age, and disease.

This article shows that a fluctuation scaling law can describe the temporal changes in the gut microbiota. This law estimates the temporal variability of the microbial population and quantitatively characterizes the path toward disease via a noise-induced phase transition. Estimation of the systemic parameters may be of clinical utility in follow-up studies and have more general applications in fields where it is important to know whether a given community is stable or not. IMPORTANCE The human microbiota correlates closely with the health status of its host. This article analyzes the microbial composition of several subjects under different conditions over time spans that ranged from days to months. Using the Langevin equation as the basis of our mathematical framework to evaluate microbial temporal stability, we proved that stable microbiotas can be distinguished from unstable microbiotas. This initial step will help us to determine how temporal microbiota stability is related to a subject’s health status and to develop a more comprehensive framework that will provide greater insight into this complex system.

To review article/abstract please click on the following link:

https://www.ncbi.nlm.nih.gov/pubmed/28345059?dopt=Abstract&utm_source=dlvr.it&utm_medium=twitter

Seres Therapeutics Announces a New SER-109 Phase 2 Clinical Study (ECOSPOR III) For Patients With Multiple Recurrent C. diff. Infections (CDI’s)

Seres Therapeutics Inc. a leading microbiome therapeutics platform company, announced on March 16th, 2017 plans to initiate a new SER-109 Phase 2 clinical study (ECOSPOR III) in patients with multiply recurrent Clostridium difficile (C. difficile) infection. The ECOSPOR III study design was finalized following a positive Type B meeting with the U.S. Food and Drug Administration (FDA). In a separate announcement today, Seres reported fourth quarter and full year 2016 financial results and provided an update on multiple ongoing microbiome clinical programs.

Seres plans to initiate a new SER-109 clinical study in approximately 320 patients with multiply recurrent C. difficile infection. Study participants will be randomized 1:1 between SER-109 and placebo. To ensure accurate measurement of C. difficile infection, diagnosis of recurrent C. difficile infection for both study entry and for endpoint analysis will be confirmed by C. difficile cytotoxin assay. Patients in the SER-109 arm will receive a total SER-109 dose, administered over three days, approximately 10-fold higher than the dose used in the prior ECOSPOR study. ECOSPOR III will evaluate patients for 24 weeks and the primary endpoint will compare the C. difficile recurrence rate in subjects who receive SER-109 verses placebo at up to eight weeks after dosing. The FDA has agreed that this new trial may qualify as a pivotal study with achievement of a persuasive clinical effect and addressing FDA requirements, including clinical and statistical factors, an adequately sized safety database, and certain CMC parameters.

“We are pleased to have received highly constructive guidance from the FDA regarding further SER-109 clinical development and we plan to initiate a new clinical study as soon as possible,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres. “Our prior SER-109 studies provided important new biological and clinical data that have advanced our pioneering microbiome therapeutic efforts. Based on our learnings and dialogue with the FDA, we believe that we are now positioned to initiate a robust clinical study that may provide the basis for SER-109 approval. There is an urgent need for improved treatments for C. difficile infection, and we believe SER-109 has great potential to address the underlying cause of the disease and become the first approved microbiome therapeutic in this new field of medicine.”

About SER-109

SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic for the treatment of multiply recurrent C. difficile infection. SER-109 is a biologically sourced consortium of bacterial spores designed to catalyze a shift in a dysbiotic gastrointestinal microbiome to a healthier state.

About Seres Therapeutics

Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. The Phase 2 study of Seres’ program SER-109 has been completed in multiply recurrent Clostridium difficile infection. Seres’ second clinical candidate, SER-287, is being evaluated in a Phase 1b study in patients with mild-to-moderate ulcerative colitis (UC). Seres is also developing SER-262, the first ever synthetic microbiome therapeutic candidate, in a Phase 1b study in patients with primary CDI. For more information, please visit www.serestherapeutics.com. Follow us on Twitter @SeresTx.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding SER-109 development plans, the timing, design, and results of the ECOSPOR III study , the potential for ECOSPOR III to provide different results than the previous ECOSPOR study, the impact analysis of prior clinical studies may have on clinical outcomes, the potential for ECOSPOR III to qualify as a Pivotal Study, dysbiosis as an underlying cause of C. difficile and other diseases.

To Read article in its entirety please click on the link below:

http://finance.yahoo.com/news/seres-therapeutics-initiate-ser-109-110000650.html;_ylt=AwrBT.EHTNBYMRUAv3hXNyoA;_ylu=X3oDMTEzbjcwdjAxBGNvbG8DYmYxBHBvcwM4BHZ0aWQDVUkwMkM0XzEEc2VjA3Ny

 

 

The Power Of Microbes In Recurrent C.diff. Infection (CDI) 94%-96% Cure Rates

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“Treating patients with recurrent C. difficile infection with microorganisms alone provides cure or reduction of symptoms at a rate many times higher than any drug or chemical that has ever been looked at. These cure rates of 94% and 96% are astronomical, and it is all due to the power of microbes, ” said Michael Sadowsky, PhD, Director of the BioTechnology Institute at the University of Minnesota, St. Paul, Minnesota.

“I think the future of medicine in the 21st century is to use the power of microbes to cure diseases.”

This new work, published in mBio, an open access journal of the American Society for Microbiology, has found which microbes are most effective in the fecal transplant procedure. The microbes from donor samples were purified and transplanted into patients to find which conferred the most benefit. The researchers used next-generation sequencing to assay the microbial populations of patients and donors.

Their findings surprised them; while they met expectations by curing around 90 percent of patients, some people who had received a placebo treatment, made up of their own fecal sample, were also cured. The researchers were able to determine that the patients cured by placebo already had some types of curative bacteria in their guts, strains that were boosted when they got the placebo.

“As opposed to what we thought, complete engraftment of microbiota is not required to cure a patient,” said Sadowsky.

“The study provides insight into which microorganisms are the most important for curing C. difficile and may allow clinicians to better tailor therapy, by improving donor material to facilitate a more rapid, effective, and lasting cure.”

Scientists can use this new data to optimize their treatments. “This paper provides us data with which microbes to supplement into our preparations,” Sadowsky concluded.

To read the article in its entirety click on the following link to be redirected:

https://www.labroots.com/trending/microbiology/4839/understanding-improving-fecal-microbiota-transplants?utm_content=buffer081c1&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer

Study shows Microbiome Differences Between Intensive Care Unit Patients Hospitalized From Healthy Patients

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The microbiome of patients admitted to the intensive care unit (ICU) at a hospital differs dramatically from that of healthy patients, according to a new study published in mSphere.

 

Researchers analyzing microbial taxa in ICU patients’ guts, mouth and skin reported finding dysbiosis, or a bacterial imbalance, that worsened during a patient’s stay in the hospital. Compared to healthy people, ICU patients had depleted populations of commensal, health-promoting microbes and higher counts of bacterial taxa with pathogenic strains – leaving patients vulnerable to hospital-acquired infections that may lead to sepsis, organ failure and potentially death.

What is dysbiosis?  Pathogens, antibiotic use, diet, inflammation, and other forces can cause dysbiosis, a disruption in these microbial ecosystems that can lead to or perpetuate disease  (1)

What makes a gut microbiome healthy or not remains poorly defined in the field. Nonetheless, researchers suspect that critical illness requiring a stay in the ICU is associated with the the loss of bacteria that help keep a person healthy. The new study, which prospectively monitored and tracked changes in bacterial makeup, delivers evidence for that hypothesis.
“The results were what we feared them to be,” says study leader Paul Wischmeyer, an anesthesiologist at the University of Colorado School of Medicine. “We saw a massive depletion of normal, health-promoting species.”
Wischmeyer, who will move to Duke University in the fall, runs a lab that focuses on nutrition-related interventions to improve outcomes for critically ill patients.

He notes that treatments used in the ICU – including courses of powerful antibiotics, medicines to sustain blood pressure, and lack of nutrition – can reduce the population of known healthy bacteria. An understanding of how those changes affect patient outcomes could guide the development of targeted interventions to restore bacterial balance, which in turn could reduce the risk of infection by dangerous pathogens.
Previous studies have tracked microbiome changes in individual or small numbers of critically ill patients, but Wischmeyer and his collaborators analyzed skin, stool, and oral samples from 115 ICU patients across four hospitals in the United States and Canada. They analyzed bacterial populations in the samples twice – once 48 hours after admission, and again after 10 days in the ICU (or when the patient was discharged). They also recorded what the patients ate, what treatments patients received, and what infections patients incurred.
The researchers compared their data to data collected from a healthy subset of people who participated in the American Gut project dataset. (American Gut is a crowd-sourced project aimed at characterizing the human microbiome by the Rob Knight Lab at the University of California San Diego.) They reported that samples from ICU patients showed lower levels of Firmicutes and Bacteroidetes bacteria, two of the largest groups of microbes in the gut, and higher abundances of Proteobacteria, which include many pathogens.
Wischmeyer was surprised by how quickly the microbiome changed in the patients. “We saw the rapid rise of organisms clearly associated with disease,” he says. “In some cases, those organisms became 95 percent of the entire gut flora – all made up of one pathogenic taxa – within days of admission to the ICU. That was really striking.” Notably, the researchers reported that some of the patient microbiomes, even at the time of admission, resembled the microbiomes of corpses. “That happened in more people than we would like to have seen,” he says.
Wischmeyer suggests the microbiome could be tracked like other vital signs and could potentially be used to identify patient problems and risks before they become symptomatic. In addition, now that researchers have begun to understand how the microbiome changes in the ICU, Wischmeyer says the next step is to use the data to identify therapies – perhaps including probiotics – to restore a healthy bacterial balance to patients.
Everyone who collaborated on the project – including dietitians, pharmacists, statisticians, critical care physicians, and computer scientists – participated on a largely voluntary basis without significant funding to explore the role of the microbiome in ICU medicine, says Wischmeyer.

 

To read this article in its entirety please click on the following link:

https://www.asm.org/index.php/journal-press-releases/94540-icu-patients-lose-helpful-gut-bacteria-within-days-of-hospital-admission?platform=hootsuite

Sources:

(1)  http://www.serestherapeutics.com

 

July 19th Join C. diff. Spores and More With Dr. Matthew Henn – Discussing The Role Of the Microbiome In Health and Disease: The Basics

 

Listen To the Live Broadcast

On  July 19th,  2016

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Listen in to the live broadcast at 10a PT,   11a MT,   12p CT,   1p ET     6p UK


C. diff. Spores and More,”™ Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:  

The Role of the Microbiome in Health and Disease: The Basics

With Our Guest

Dr. Matthew Henn,  Senior Vice President, Head of Drug Discovery and Bioinformatics

Matthew Henn is the Senior Vice President and Head of Drug Discovery & Bioinformatics of Seres Therapeutics, Inc. He has more than 16 years of combined research experience in microbial ecology, genomics, and bioinformatics that spans both environmental and infectious disease applications.

Dr. Henn’s research has focused on the development, implementation, and application of genomic technologies in the area of microbial populations and their metabolic functions. Prior to joining Seres, he was the Director of Viral Genomics and Assistant Director of the Genome Sequencing Center for Infectious Diseases at the Broad Institute of MIT and Harvard.

Join us on Tuesday, July 19th as Dr. Henn provides the foundation educational information about the microbiome by answering the fundamental questions of what is it, why is it important, how does it impact patients with C. difficile infections, and what are the possibilities of the microbiome as a therapeutic target for future drugs.  This interview will solely be with Dr. Matthew Henn, Senior Vice President and Head of Drug Discovery & Bioinformatics at Seres Therapeutics, Inc,.

Seres Therapeutics is a leading microbiome therapeutics company dedicated to creating a new class of medicines to treat diseases resulting from imbalances in the microbiome.  These first-in-class drugs, called Ecobiotics®, are ecological compositions of beneficial organisms that are designed to restore a healthy human microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.

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C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

Take our show on the go…………..download a mobile app today

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Programming for C. diff. Spores and More ™  is made possible through our official  Sponsor;  Clorox Healthcare

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C. difficile Infection (CDI) Prevention, Treatment, Environmental Safety, Research, Clinical Trials Being Discussed with World Topic Experts On September 20th In Atlanta, Georgia USA

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September 20th

It is with great pride and certainty in the power of the healthcare community to present the 4th Annual International Raising. C. diff. Awareness Conference and Health Expo

being hosted at the

DoubleTree by Hilton — Atlanta Airport 
3400 Norman Berry Drive
Atlanta,Georgia 30344 USA  (Hotel Phone: 1-404-763-1600)

Doors open at 7:15 a.m — Sign In and Continental Breakfast

Conference begins at: 7:30 a.m. – 5:00 p.m.

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Raising C. difficile awareness is essential to build upon and advance existing knowledge and necessary for overcoming the challenges our healthcare communities are faced with today.

“None of us can do this alone — All of us can do this together”

Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC).   C. diff. is a leading cause of infectious disease death worldwide; 29,000 died within 30 days of the initial diagnosis in the USA.   Previous studies indicate that C. diff. has become the most common microbial cause of healthcare-associated infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone.

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Cdiff2015-1Clinical professionals gather for one day to present up-to-date data to expand on the existing knowledge and raise awareness of the urgency focused on a Clostridium difficile infection (CDI) —

    • Prevention
    • Treatments
    • Research
    • Environmental Safety
    • Clinical trials and studies

WITH

  • Microbiome research, studies
  • Infection Prevention
  • Fecal Microbiota Restoration and Transplants for Adults & Pediatrics
  • A Panel Of C. diff. Infection Survivors
  • Antibiotic Stewardship
  • Healthcare EXPO
    ……………………and much more.

You won’t want to miss out on this opportunity to learn from
International topic experts delivering data directed at evidence-based
prevention, treatments, and environmental safety in the C. diff.
and healthcare community.

Gain insights on September 20th that will not be available anywhere else with an opportunity to receive up-to-date data on major topics in this program being presented in one day.

5 Leading reasons to attend this dynamic conference:

  • Learn from leading healthcare professionals, clinicians, researchers, and industry.
  • Networking opportunities with new and reconnect with those in the healthcare community with similar interests.
  • Gain breakthrough results through research in progress and gaining positive results. Programs focused on Antibiotic-resistance such as the  Antibiotic Stewardship making a difference. Front line developments in progress focused on C. diff. infection prevention, treatments, environmental safety.
  • Implement and share the knowledge well after the conference ends.  Every attendee receives a booklet with guest speakers information, media to review audio programs, and Health Expo Sponsor information focused on the important agenda topics.
  • Embrace the opportunity, with all of the topic experts presenting, and hold the conference in the highest priority from the participation in this conference to an audience of medical students, and fellow healthcare professionals, who will benefit the most from the data and gain tools to overcome the barriers facing healthcare each day.

“The information and up-to-date studies shared at the 2015 conference added to an existing knowledge base that helps us to continue delivering quality care in the medical community.”   Linda Davis, RN,BSN

 ……………………………………………………………………………………………………………..

REGISTRATION FEES:

$75.00  —  Conference Registration

$30.00  —  Student Conference Registration (Student ID To Be Presented At the Door)

TO REGISTER Click on the “Raising C. diff. Awareness” Ribbon below

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Room accommodations are available —  Complete and Confirm 

by August 19th to reserve your hotel reservations.   

To create a reservation please click on the DoubleTree By Hilton Logo below – – – – – –

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 A suggested travel coordinator, for your convenience

LibertyTraveldownloadMichael Beckman — Team Leader,  Liberty Travel, 467 Washington Street, Boston, MA  02111
617-936-2435
Michael.Beckman@flightcenter.com

 For Additional Information visit the C Diff Foundation Website:

https://cdifffoundation.org/

https://cdifffoundation.org/

And Click on the 2016 September Conference Tab

 

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