Saturday, 31 August 2019

Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation

Fecal transplants

On June 13, 2019, the Food and Drug Administration (FDA) informed health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT).  Bacterial infections caused by multi-drug resistant organisms (MDROs) have occurred due to transmission of a MDRO from use of investigational FMT, resulting in the death of one individual.

Because these serious adverse reactions occurred with investigational FMT, FDA has determined that additional protections are needed for any investigational use of FMT.  FDA has notified all Investigational New Drug (IND) holders of these requirements and that they need to implement these new requirements no later than July 15, 2019.

FDA has received inquiries from non-IND holders since the release of the June 13, 2019 safety communication, such as those who may be using FMT under enforcement discretion, regarding the additional screening and testing procedures. 

For details, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 30 August 2019

Diagnosing Children’s Pneumonia and Other Respiratory Diseases with Ultrasound

MSF/Doctors Without Borders Study: Non-Physician Clinicians in South Sudan Diagnose Children’s Pneumonia and Other Respiratory Diseases with Ultrasound Accurately After Short Training

New research shows that non-physician clinicians in settings with health care resource shortages can learn to use point-of-care ultrasound (POCUS) to accurately diagnose pneumonia in children, according to a new study published today in the American Journal of Tropical Medicine and Hygiene.

Pneumonias are the leading cause of deaths in children under 5 years of age worldwide, particularly in low-resource settings such as Aweil, South Sudan where the study was conducted. Unfortunately, in these settings the diagnosis of pneumonia can be difficult, due to either lack of access to X-ray or overly sensitive clinical criteria. POCUS is a novel diagnostic method in which non-radiologists perform bedside ultrasounds. Lung POCUS, in particular, has been shown to improve the diagnosis of pneumonia. However, there are limited data using lung POCUS in low-resource settings.

Researchers from Médecins Sans Frontières (MSF), Icahn School of Medicine at Mount Sinai, University of Michigan School of Medicine, and the University of Washington examined the feasibility of training Clinical Officers (COs)—non-physician clinicians—in South Sudan to perform lung POCUS to differentiate among causes of lower respiratory tract disorders. Six COs underwent a brief training and subsequently each performed 60 lung POCUS studies on hospitalized pediatric patients under 5 years of age with criteria for pneumonia. Two blinded experts, with a tiebreaker expert adjudicating results, evaluated both the image quality and the CO’s interpretations. The experts rated 99.1% of the images acceptable and 86.0% of the CO interpretations appropriate. The researchers said the results of this study can be used to guide development of policies that address unmet diagnostic needs for pneumonia and thereby reduce associated medical problems and deaths in children in low resource settings.

>> Abstract

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Thursday, 29 August 2019

Contamination control white paper

Microbiology in action!

Effective contamination control requires high-quality cleaning equipment and specialized techniques. It does not matter how effective a cleaning agent is if the cleaning technique utilized by a cleanroom operator is poor. Today’s critical cleaning professionals recommend the use of multi-bucket mopping systems for maximum efficiency and removal of contaminants.

Deciding which cleaning method is best for guaranteed compliance with today’s cleanroom standards is a challenging process. To overcome this, we’ve illustrated practical cleaning and disinfecting techniques to assist in your decision of the appropriate method to utilize for overall cleanliness and absolute contamination control.

READ MORE: Biocontamination control for pharmaceuticals and healthcare

As a leading innovator of cleaning technologies, Perfex brings more than 90 years of experience and expertise in cleanroom cleaning tools and development to the pharmaceutical manufacturing market.

Foe details, see: Contamination control

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 28 August 2019

Cells synchronize to release toxins in unison

Crouching in the boot-sucking mud of the Baylands Nature Preserve in Palo Alto, Manu Prakash, associate professor of bioengineering at Stanford University, peered through his Foldscope -- a $1.75 origami microscope of his own invention -- scrutinizing the inhabitants of the marsh's brackish waters. With his eye trained on a large single-cell organism, called Spirostomum, he watched it do something that immediately made it his next research subject.

This observation, made through a simple tool only five miles from Prakash's lab, has now led him and colleagues to the discovery of a new form of communication between cells, which they detail in a paper published July 10 in Nature. Without touching and without electrical or chemical signals, individual Spirostomum can coordinate their ultrafast contractions so closely that groups of them appear to shrink simultaneously -- a reaction to predators that makes them release paralyzing toxins in sync.

The researchers solved this mystery by applying insights from separate research being conducted by Deepak Krishnamurthy, another graduate student in the Prakash lab, on how an individual cell can sense the movement of water around it. Once they observed the flow fields around Spirostomum, it became clear that they were communicating via hydrodynamic flows.

READ MORE: Genetically engineering yeast to improve understanding of how cells work


Arnold J. T. M. Mathijssen, Joshua Culver, M. Saad Bhamla, Manu Prakash. Collective intercellular communication through ultra-fast hydrodynamic trigger waves. Nature, 2019; DOI: 10.1038/s41586-019-1387-9

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 27 August 2019

Modernizing FDA's New Drugs Regulatory Program

FDA’s Center for Drug Evaluation and Research (CDER) has embarked on an initiative to modernize the New Drugs Regulatory Program. This effort will allow CDER to better serve patients and better support staff in their work to carry out the center’s mission – to protect and promote health by making sure that human drugs are safe and effective for their intended use, that they meet established quality standards, and that they are available to patients.

The modernization of the New Drugs Regulatory Program will be a long-term process of continuous improvement involving multiple initiatives. The modernization focuses on six strategic objectives:

Scientific Leadership

Grow our scientific expertise and clarify pathways to regulatory approval.
Scientific leadership is vital for our ongoing success. Addressing unmet medical needs is an important part of our public health mission. As such, we aspire to expand our scientific expertise to enable better regulatory decisions. We will continue to hire talented scientists, work to develop long-term career paths for them, so they can become our next generation of seasoned leaders. We will proactively collaborate with academic medical scientists and patient/disease advocates, provide scientific vision and direction, and strategically foster drug development.

Integrated Assessment

Critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements.
We are implementing a new process with early identification and focus on the important application-specific issues, uses a team-based interdisciplinary model, and increasingly incorporates the patient perspective, providing an integrated assessment.  

Benefit-Risk Monitoring

Systematically monitor the benefits and risks of approved drugs pre- and post- approval to effectively protect the American public.
Ensuring safety of all drugs remains a key component of our mission and our new plans.  We will work to establish a unified post-market safety surveillance framework to monitor the benefits and risks of drugs across their lifecycles, both before and after approval.

Managing Talent

Attract, develop, and retain outstanding people.
We will use various hiring mechanisms such as 21st Century Cures Act pay authorities to enhance our efforts to retain our current talented staff and attract and recruit future talented staff for the New Drugs Regulatory Program, assuring the next generation of leaders.

Operational Excellence

Standardize workflow, business processes, roles, and responsibilities to improve operational efficiency, and enable our scientists to focus on science.
As part of the proposed organizational structure changes within the Office of New Drugs (OND), we plan to standardize various regulatory and business processes. Our proposed organizational structure creates a central office of regulatory, program and administrative operations servicing all of OND. Our aim is to enable our scientific and clinical experts to focus on what they know best – science and medicine – and allow our regulatory and administrative experts to manage the many processes we conduct.

Knowledge Management

Facilitate the identification, capture, distribution and effective use of information.
Knowledge management is essential to leverage the data we receive from outside sources as well as what we generate from within the FDA. Vast and diverse information is submitted to and generated by the New Drugs Regulatory Program. We plan to markedly expand knowledge management capabilities, which will allow us to better retrieve and utilize information that will improve decision-making and accountability.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 26 August 2019

Audit and Control for Healthcare Manufacturers: A Systems-Based Approach

Compliance is an affirmative indication or judgement that the supplier of a product or service has met the requirements of the relevant specifications, contract or regulation; also the state of meeting the requirements. Compliance is something that meets both the text and the spirit of a requirement. A key way to assess compliance is through auditing.

Auditing is the theme of a new book from Tim Sandle and Jennifer Sandle.

If designed and implemented appropriately, audits can provide valuable information for prevention of issues. The goal is to catch problems before they impact product quality, and putting patients at risk.  In addition to the regulations noted, the following points will contribute to an effective audit/control program:
  • Systems-Based Audits and Inspections
  • Defining Metrics
  • Risk Based Approach to Quality Auditing
  • Auditor Techniques
  • Documentation and Reporting Techniques
  • Computerized Systems Audits and Data Integrity Requirements

Each point is developed in detail in the book, together with practical examples and applicable regulations. The latter point has become an area of increasing attention and comment by the regulatory agencies. 

The book outlines why audits are important and how they feed into the quality system. The book has the objective of helping those who need to carry out audits. The reference is:

Sandle, T. and Sandle, J. (2019) Audit and Control for Healthcare Manufacturers: A Systems-Based Approach, PDA / DHI Books, River Grove, IL, USA

For further details, see the PDA Bookstore:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 25 August 2019

How plague pathogens trick the immune system

Yersinia plague bacterium

Yersinia have spread fear and terror, especially in the past, but today the plague pathogens have still not been completely eradicated. The bacteria inject various enzymes, including the enzyme YopO, into the macrophages of the immune system. There it is activated and prevents the defense cells from enclosing and digesting the plague bacteria. Using the latest methods, scientists from the Institute of Physical and Theoretical Chemistry at the University of Bonn have now deciphered how YopO changes its shape and thus contributes to confusing the immune system. The results have now been published in the journal Structure.

Yersinia also includes the plague pathogen, which caused fear and terror worldwide until the discovery of antibiotics. The major epidemics are over, but the World Health Organization (WHO) reported a total of 1451 deaths in 21 countries between 1978 and 1992. Plague bacteria are also found in wild rodents. The transmission occurs mainly via fleas, but also via droplet infection. "Yersinia trick the macrophages of the immune system," says Dr. Gregor Hagelüken from the Institute of Physical and Theoretical Chemistry at the University of Bonn.

The structural biologist has already done research in Yersinia as a PhD student at the Helmholtz Centre for Infection Research in Braunschweig. The special feature of the plague pathogens is a kind of syringe with which they inject the YopO and some other enzymes into the macrophages of the immune system. However, YopO only becomes active when it binds to the actin of the scavenger cell. Normally, the structural protein actin helps the phagocyte to form protrusions with which it flows around the pathogens and then disolves them into small pieces. During this process, the macrophage calls for help from other defense cells.

The scientists at the University of Bonn therefore used several instruments from the structural elucidation toolbox. Together with Dr. Dmitri Svergun from the European Molecular Biology Laboratory in Hamburg, they used the PETRA III electron accelerator of the German Electron Synchrotron DESY. "The extremely intense and focused X-rays can be used to study the overall structure and structural changes of enzymes dissolved in water with the aid of small-angle X-ray scattering," said Svergun.

In addition, the researchers attached spin markers to certain positions of YopO and actin. These function like survey points in the landscape at which, for example, the exact location of a property can be determined. "Using the spin markers, we can use a molecular ruler -- the PELDOR method -- to measure the nanometer distances between these positions and thus determine how YopO and actin change shape," reports Hagelüken. So far it has been presumed that YopO performs a folding movement like scissors as soon as it binds to actin.


Martin F. Peter, Anne T. Tuukkanen, Caspar A. Heubach, Alexander Selsam, Fraser G. Duthie, Dmitri I. Svergun, Olav Schiemann, Gregor Hagelueken. Studying Conformational Changes of the Yersinia Type-III-Secretion Effector YopO in Solution by Integrative Structural Biology. Structure, 2019; DOI: 10.1016/j.str.2019.06.007

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 24 August 2019

New antibiotics effective without triggering resistance

Not only are they effective against Gram-positive and negative multi-resistant bacteria, they also appear not to trigger resistance when used to treat infection in mice. Such are the promises of the two new antibiotics created by Prof. Brice Felden and his team at the Inserm and Université de Rennes 1 'Bacterial Regulatory RNAs and Medicine' joint laboratory (U1230), in conjunction with a team from the Rennes Institute of Chemical Sciences (ISCR). This French advance could bring both fresh impetus and new possibilities for fighting antibiotic resistance worldwide.

Antibiotics have saved so many lives over the previous century of their use in humans that they are considered to be one of the major breakthroughs of contemporary medicine. Unfortunately, growing resistance is gradually rendering them ineffective, with the threat of catastrophic public health consequences should this trend continue much longer. The few new antibiotics being brought to market essentially consist of so-called me-too drugs -- meaning that they are derived from existing classes of antibiotics.

Researchers from Inserm and Université de Rennes recently identified a new bacterial toxin which they transformed into potent antibiotics active against various bacteria responsible for human infections, whether Gram-positive or negative. "It all started with a fundamental discovery made in 2011," explains Brice Felden, Director of the Bacterial Regulatory RNAs and Medicine laboratory in Rennes. "We realized that a toxin produced by Staphylococcus aureus whose role is to facilitate infection is also capable of killing other bacteria present in our body. What we had identified was a molecule with dual toxic and antibiotic properties. We thought that if we could separate these activities, we would be able to create a new antibiotic non-toxic to the body. A challenge that we accepted!"

READ MORE: How bacteria communicate

In conjunction with the team of ISCR chemist Michèle Baudy Floc'h, a new family of so-called peptidomimetics was synthesized. As their name suggests, these peptides are inspired by the existing natural bacterial peptides but have been shortened and modified. Out of the twenty molecules created, two proved effective against resistant Staphylococcus aureus and Pseudomonas aeruginosa in mouse models of severe sepsis or skin infection. In addition, no toxicity to the other cells and organs, whether in animals or human cells was observed. These new compounds are well tolerated at their active doses -- and even beyond -- and are devoid of the renal toxicity issues often encountered with this type of compound. "We tested them at doses 10 to 50 times higher than the effective dose without seeing toxicity" specifies Felden, adding that "the participation and imagination of the team and our chemist colleagues was needed to devise the most active molecules possible."


Irène Nicolas, Valérie Bordeau, Arnaud Bondon, Michèle Baudy-Floc’h, Brice Felden. Novel antibiotics effective against gram-positive and -negative multi-resistant bacteria with limited resistance. PLOS Biology, 2019; 17 (7): e3000337 DOI: 10.1371/journal.pbio.3000337

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Friday, 23 August 2019

Protection mechanism in bacteria

Gram negative bacteria can cause diseases such as pneumonia, cholera, typhoid fever and E. coli infections, as well as many hospital acquired infections. They are increasingly resistant to antibiotics -- and this is partly because of the way they are built.

Gram negative bacteria are surrounded by a double membrane that forms a highly effective protective barrier and makes the cell far more resilient to antibiotics. The outer of these two membranes is composed of two types of molecule, phospholipid and lipopolysaccharide (LPS) in a unique asymmetric architecture, with LPS on the outside of the membrane and phospholipid on the inside. It is this architecture that makes gram-negative bacteria particularly resistant to antibiotics.

Understanding how these bacteria make this outer membrane could lead to the identification of new ways to combat bacterial infections, as this membrane is essential for bacterial survival.

Scientists at the University of Birmingham have recently made a step forward in understanding this process by identifying the first mechanism involved in the movement of phospholipid molecules towards this membrane.

Using biophysical techniques including x-ray crystallography and nuclear magnetic resonance, the Birmingham team were able to monitor the movement of phospholipids from the inner membrane towards the outer membrane directly through a series of proteins that form a pathway known as the Mla pathway. This pathway has previously been shown to be involved in disease but its exact function was not known. These results provide the first evidence of a protein machinery involved in these transport processes and opens up the possibility of targeting it for antibiotic development.

READ MORE: Artificial intelligence used to identify bacteria accurately


Gareth W. Hughes, Stephen C. L. Hall, Claire S. Laxton, Pooja Sridhar, Amirul H. Mahadi, Caitlin Hatton, Thomas J. Piggot, Peter J. Wotherspoon, Aneika C. Leney, Douglas G. Ward, Mohammed Jamshad, Vaclav Spana, Ian T. Cadby, Christopher Harding, Georgia L. Isom, Jack A. Bryant, Rebecca J. Parr, Yasin Yakub, Mark Jeeves, Damon Huber, Ian R. Henderson, Luke A. Clifton, Andrew L. Lovering, Timothy J. Knowles. Evidence for phospholipid export from the bacterial inner membrane by the Mla ABC transport system. Nature Microbiology, 2019; DOI: 10.1038/s41564-019-0481-y

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Thursday, 22 August 2019

'Curvy bacteria' weigh the benefits of different shapes

Research by scientists into why some bacteria have different shapes has found that a curved shape can make it easier to find food. Computer simulations were used to compare the swimming of differently shaped bacteria. Results showed that a curved shape can be beneficial for efficient swimming and for finding food through the use of chemical trails (known as chemotaxis) - but at the expense of higher cell construction costs.

Life Sciences researchers at the University of Lincoln conducted computer simulations to compare the swimming of differently shaped bacteria. Results showed that a curved shape can be beneficial for efficient swimming and for finding food through the use of chemical trails (known as chemotaxis) -- but at the expense of higher cell construction costs.
This indicates that some bacteria species may balance the cost and benefits of their shape, depending on their environment and activity levels.

Before now it has not been understood what determines the different shapes of bacteria. While the shape of large creatures is driven by the effects of gravity and streamlining, for microscopic organisms these do not have such an impact.

Prof. Stuart Humphries, Professor of Evolutionary Biophysics at the University of Lincoln, said: "This work opens the door to asking a number of questions, for instance whether disease-causing bacteria have different shapes, or if different cell shapes improve the abilities of microbes we harness for industrial purposes."

READ MORE: Cilia: 'The bouncer' of bacteria

Prof. David Smith, Professor of Applied Mathematics at the University of Birmingham said: "This research shows how state of the art maths and supercomputing simulation, used alongside extensive survey of a wealth of microscopy data, enables us to explore and explain aspects of the immense diversity of the living world which have hitherto been impossible."


Rudi Schuech, Tatjana Hoehfurtner, David J. Smith, Stuart Humphries. Motile curved bacteria are Pareto-optimal. Proceedings of the National Academy of Sciences, 2019; 201818997 DOI: 10.1073/pnas.1818997116

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday, 21 August 2019

Microbiome-directed therapeutic foods tackle childhood malnutrition

The results of two new reports, linking the growth of infants and children to healthy development of gut microbiomes, were published in Science on July 12th. Researchers utilized microbiome-directed complementary foods in an approach that focuses on selectively boosting key growth-promoting gut microbes using ingredients present in affordable, culturally acceptable foods.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday, 20 August 2019

Good Distribution Practice (GDP) Symposium

MHRA have released a summary of the recent Good Distribution Practice (GDP) Symposium. The focus of the 2018 GDP symposium was maintaining compliance in a changing world.

One of the interesting things to note is with the top five deficiencies were reported as follows:

  • Chapter 1 Quality Management – 38% of inspections
  • Chapter 9 Transport – 25% of inspections
  • Chapter 5 Qualification of Customers – 20% of inspections
  • Chapter 6 Returned Medicinal Products – 18% of inspections
  • Chapter 2 Responsible Person – 15% of inspections

From this, organizations should be putting together personal learning action plans, namely:

  • identification of role improvement opportunities
  • evaluation of learning needs
  • increasing knowledge of licence activities
  • undertaking new learning opportunities
  • maintaining learning records

Full details can be found here:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday, 19 August 2019

Pharmaceutical microbiology: current and future challenges

On 15th October 2018 Tim Sandle delivered the key note address to the PDA Microbiology Europe conference. Tim Sandle has written an article which takes the form of an edited transcript of the presentation.

Whilst there is a continuing need for monitoring of the environment and conducting standardized laboratory tests, pharmaceutical microbiology has moved on to embrace:
  • Microbiological audits;
  • Rapid microbiological methods;
  • Conducting risk assessments, both proactive in terms of minimizing contamination and reactive, in terms of addressing microbial data deviations;
  • Ensuring that processes meet ‘quality by design’ principles;
  • And getting the microbiologist away from the bench and into the plant.

These themes are captured in the auricle, for which the reference is:

Sandle, T. (2019) Pharmaceutical microbiology: current and future challenges, Pharmig News, Issue 75, pp12-15

For details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Sunday, 18 August 2019

Some Useful Tips to Open PCD Franchise Company

India carefully monitors their healthcare services, so opening a pharma company in India can be a good business idea. In this guide, we will explain how to open a monopoly pharma franchise company in India. Find out the requirements, read the tips for choosing a place to place a new business and consult the list of the best franchises currently operating in India.

A guest post by Satvir Singh

Open a PCD pharma franchise in India:

In addition to selling over-the-counter drugs, you can sell health and beauty products, such as cosmetics, baby products, and food for specific needs, such as celiac disease, diabetics or low-calorie products, and most veterinary drugs.

Do I need to have a pharmaceutical education to open a pharmacy in India? This may surprise you, but the answer is no. Having 3-5 years of working experience in the pharma sector is enough. But if you do not have an education, you will definitely need to hire a qualified pharmacist to sell medicines. This means that the owner of the company can be anyone, but in this case he will have to consider the need for constant cooperation with one or more certified pharmacists.

The presence of a pharmacist is not the only requirement required to open a pharmacy.

Requirements for opening a pharmacy in India

As we explained several paragraphs above, even if you do not need to have a pharmacist diploma to open a pharmacy, there are other requirements and procedures that must be followed. For example, you need to get a ISO, GMP and WHO certificates if you decide to sell pharma product and supplements, even if they are packaged.

As for opening a pharmacy, you also need:

Request registration of a pharmacy at the Ministry of Health & FSSAI
Make a message about starting a business in the municipality

Register with the Chamber of Commerce.

The second and third points are not different from the procedure for opening any other business. Registration of activities in the Ministry of Health is the only way to organize the subsequent delivery of drugs to the warehouse of the outlet. In fact, after checking the submitted documentation, the pharmacy will be assigned the code necessary for the purchase of medicines. In addition, after obtaining permission from the Ministry of Health, the company will be registered in the database of authorized pharmacies and pharmacies and, therefore, can sell its products even through the Internet.

How to choose a place for the pharmacy: a few tips?

Some franchise requires certain functions from the premises in which the franchisee’s pharmacy will be opened. However, regardless of this, keep in mind that it is always recommended to open a company in areas with a large inflow of people, in any case, in urban centers, at least medium-sized.
Always make sure that there are no other suppliers in the immediate locality, and in any case carefully consider whether a potential clientele, based on the population of the area, can be sufficient for a new point of sale.

As for the size of the place, an average / large area is always recommended. Keep in mind that you definitely need a medium size store room. You can take assistance from the top PCD pharma franchise company listed on PharmafranchiseeIndia . Our experts are always there to help you out and clear your doubts and answer your questions 24/7.

Careless disposal of medicines increases antimicrobial resistance

There are a number of ways by which antimicrobial resistance can spread, and one that is of growing concern is the disposal of medicines by consumers down sinks and toilets. A new technique can help to assess the extent of the spread.

Antimicrobial resistance is an established global health problem which is characterized by the ability of microorganisms to counter the effects of medicines. The threat posed by this to human populations is such that the tackling of the problem is classed as one of the Sustainable Development Goals of the World Health Organization.

One factor that is not helping with the rise of antimicrobial resistance is the way that medicines are disposed of. Various reports indicate the significant role of the environment in the emergence and spread of resistance to antimicrobials. Antimicrobials, like antibiotics, enter the environment through too many people choosing to dispose of medicines themselves at home (such as by flushing the unwanted medications down a sink of via the toilet) rather than returning the unused medication to the originating pharmacy for safe disposal.

As to how widespread the presence of antimicrobial organisms are in the sewage system and the extent that this related to human activity has been difficult to discern, particularly any variations with the patterns of resistance worldwide. A new method, based on a mix of genetics and statistical analysis aims to address this knowledge gap.

The novel method, which comes from the Technical University of Denmark, involves assessing genetic materials recovered from untreated sewerage. The technique demonstrates how this analysis can assist scientists which identifying antimicrobial resistance patterns in areas where there are human populations worldwide. The focus of the research, and where data was collected for the analysis, was in regions of Africa, Asia and South America. These data, where it was found there are high levels of antimicrobials, were contrasted with North America and Western Europe, where levels were found to be relatively lower.

These patterns were visualized through an examination of the genetic materials extracted from untreated sewerage in 74 cities, from samples drawn across 60 countries. The follow-up step was to analyze the data using statistical methods. From this, the researchers were able to estimate patterns of resistant bacteria across different global regions.

According a summary by Science Development: "The countries standing out as having the most divergent distribution of antimicrobial resistance genes were Brazil, India and Vietnam, suggesting that these countries could be hot spots for emergence of novel antimicrobial resistance mechanisms."
The concern for less developed regions is that antimicrobial resistance gene abundance strongly correlates with socio-economic, health and environmental factors, meaning that countries with fewer resources and poorer populations will face greater challenges in addressing the concern.
The new method to assess resistance patterns has been reported to the journal Nature Communications, where the paper is titled "Global monitoring of antimicrobial resistance based on metagenomics analyses of urban sewage."

Written by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday, 17 August 2019

Is anxiety linked to our gut microbiome?

Microbiome research has advanced considerably since the first results from the U.S. National Institutes of Health led Human Microbiome Project were released. One area of interest is the connection between our microorganisms and anxiety symptoms. At first glance, the connection between the array of different microorganisms that are found within the human gut and feelings such as anxiety is not an obvious one. However, there is a growing level of evidence that variations within microbial communities are influential upon metabolic processes.
Human microbiome
The human microbiome refers to the totality of microorganisms and their genetic interactions within a given niche. Our understanding of the microbiome has advanced following a study of 300 men and women, who volunteered to take part in an international study. The advancement in understanding relating to developments with the methods used to characterize the microorganisms (including metagenomics) and the in-depth nature of the study, relating to the sampling of many body parts over a prolonged period of time, and drawing upon of the subjects from different geographical locales.
FDA microbiologist prepares DNA samples for gel electrophoresis analysis
FDA microbiologist prepares DNA samples for gel electrophoresis analysis
FDA / File
With the specific effects in relation to the human gut, then the understanding by scientists of the gut-brain axis has increased during the past ten years, suggesting a bidirectional nature between the gut and brain microbiome interactions. This includes a connection relating to the pathophysiology and pathogenesis of irritable bowel syndrome (IBS), as an example.
In another research field, there is growing evidence of psychiatric and neurologic disorders like autism spectrum disorders, affective disorders, Parkinson's disease, and multiple sclerosis, being connected to the human gut microbiome.
The reason for this is that, with most people, the gut microbiota assist with the healthy functioning of the immune system. Furthermore, organisms assist with the metabolism by contributing inflammatory mediators, vitamins, and nutrients. Moreover, microbiologists have demonstrated that the intestinal microbiota can modulate communication between the intestinal tract and human brain via the nervous, immune, and endocrine systems.
It may be possible to treat superbugs with a predatory bacteria.
It may be possible to treat superbugs with a predatory bacteria.
University of Nottingham
However, when the intestinal microbial balance is altered, then changes occur and these can be manifest in terms of physical, and potentially mental, symptoms. One area being investigated in relation to a mental system is anxiety.
Anxiety is an emotion characterized by an inner turmoil. It is often accompanied by nervous behaviour, somatic complaints, and rumination. The condition includes subjectively unpleasant feelings of dread over anticipated events. When experienced regularly the individual may suffer from an anxiety disorder. The global incidence of anxiety disorder is estimated to be between 3-25 percent. Typical treatment for anxiety is usually psychopharmacological therapies and psychotherapy.
New research
With the new research, scientists have attempted to see if anxiety symptoms can be improved by regulation of intestinal microorganisms. By assessing some 3,334 published articles the researchers focus on 21 major studies. Across these studies,1,503 participants included "patients with IBS (10 studies), healthy controls (six studies) and other patients with chronic diseases such as chronic fatigue syndrome (CFS), rheumatoid arthritis (RA), obesity, fibromyalgia, and type 2 diabetes mellitus."
Of the 21 studies, 14 had chosen probiotics as interventions to regulate intestinal microbiota (IRIFs), and seven chose non-probiotic ways, such as adjusting daily diets. Those studies that utilized "interventions regulating intestinal flora" consisting of probiotics with Lactobacillus alone or a mixture of LactobacillusStreptococcus, and Bifidobacterium, showed some positive results. Overall, 11 of the 21 studies suggested a positive effect on anxiety symptoms by regulating intestinal microbiota, meaning that more than half (52 percent) of the studies showed this approach to be effective.
Some of the bacteria found by scientists in 3.5-billion-year-old fossils are now extinct  while oth...
Some of the bacteria found by scientists in 3.5-billion-year-old fossils are now extinct, while others are similar to contemporary microbes
To draw these conclusions the review was subjected to meta-analysis, considering the research design, subjects, interventions, and anxiety assessment scales. This drew out the connected between anxiety and disturbances to the gut microbiome and indicated that it may be possible to regulate the intestinal microbiota through the use of probiotics, although further research will be required.
The researchers conclude: "We find that more than half of the studies included showed it was positive to treat anxiety symptoms by regulation of intestinal microbiota.
"There are two kinds of interventions (probiotic and non-probiotic interventions) to regulate intestinal microbiota, and it should be highlighted that the non-probiotic interventions were more effective than the probiotic interventions. More studies are needed to clarify this conclusion since we still cannot run meta-analysis so far."
Research paper
The new research has been published in the British Medical Journal, with the research paper titled “Effects of regulating intestinal microbiota on anxiety symptoms: A systematic review.”

Written by Dr. Tim Sandle, Pharmaceutical Microbiology

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